diff --git a/README.md b/README.md index f6e4d6e..764b9a8 100644 --- a/README.md +++ b/README.md @@ -101,6 +101,64 @@ SOA_EAGER_BCP_POPULATION=1 | `CDISC_API_KEY` | _(shell env)_ | CDISC Library API key — set in shell, not `config.env` | | `CDISC_SUBSCRIPTION_KEY` | _(shell env)_ | CDISC Library subscription key — set in shell, not `config.env` | +### Configurable CT codelist codes (dropdowns) + +Many dropdowns in the UI (Epoch Type, Arm Type, Role Type, Timing Type, +etc.) present CDISC controlled terminology preferred terms while storing +the underlying codelist C-code in the database. The C-code that backs +each dropdown is itself configurable via `config.env` — edit the value +and restart the server to point that dropdown at an alternate/custom +codelist. Defaults are read by +[`src/soa_builder/web/codelist_config.py`](src/soa_builder/web/codelist_config.py). + +```ini +CODELIST_EPOCH_TYPE=C99079 +CODELIST_ARM_TYPE=C174222 +CODELIST_ARM_DATA_ORIGIN_TYPE=C188727 +CODELIST_ROLE_TYPE=C215480 +CODELIST_ORGANIZATION_TYPE=C215480 +CODELIST_AMENDMENT_REASON=C207415 +CODELIST_AMENDMENT_IMPACT_TYPE=C215481 +CODELIST_GEOGRAPHIC_SCOPE_TYPE=C207412 +CODELIST_GOVERNANCE_DATE_TYPE=C207413 +CODELIST_STUDY_TITLE_TYPE=C207419 +CODELIST_INTERVENTION_ROLE=C207417 +CODELIST_INTERVENTION_TYPE=C99078 +CODELIST_INTERVENTION_UNIT=C66781 +CODELIST_OBJECTIVE_LEVEL=C188725 +CODELIST_ENDPOINT_LEVEL=C188726 +CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING=C127262 +CODELIST_ENCOUNTER_CONTACT_MODE=C171445 +CODELIST_TIMING_TYPE=C201264 +CODELIST_TIMING_RELATIVE_TO_FROM=C201265 +``` + +| Variable | Default | Dropdown / feature | +|---|---|---| +| `CODELIST_EPOCH_TYPE` | `C99079` | Epoch Type | +| `CODELIST_ARM_TYPE` | `C174222` | Arm Type | +| `CODELIST_ARM_DATA_ORIGIN_TYPE` | `C188727` | Arm Data Origin Type | +| `CODELIST_ROLE_TYPE` | `C215480` | Study Role Type | +| `CODELIST_ORGANIZATION_TYPE` | `C215480` | Organization Type | +| `CODELIST_AMENDMENT_REASON` | `C207415` | Amendment Reason | +| `CODELIST_AMENDMENT_IMPACT_TYPE` | `C215481` | Amendment Impact Type | +| `CODELIST_GEOGRAPHIC_SCOPE_TYPE` | `C207412` | Geographic Scope Type | +| `CODELIST_GOVERNANCE_DATE_TYPE` | `C207413` | Governance Date Type | +| `CODELIST_STUDY_TITLE_TYPE` | `C207419` | Study Title Type | +| `CODELIST_INTERVENTION_ROLE` | `C207417` | Study Intervention Role | +| `CODELIST_INTERVENTION_TYPE` | `C99078` | Study Intervention Type | +| `CODELIST_INTERVENTION_UNIT` | `C66781` | Study Intervention Dose Unit | +| `CODELIST_OBJECTIVE_LEVEL` | `C188725` | Objective Level | +| `CODELIST_ENDPOINT_LEVEL` | `C188726` | Endpoint Level | +| `CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING` | `C127262` | Encounter Environmental Setting | +| `CODELIST_ENCOUNTER_CONTACT_MODE` | `C171445` | Encounter Contact Mode | +| `CODELIST_TIMING_TYPE` | `C201264` | Timing Type | +| `CODELIST_TIMING_RELATIVE_TO_FROM` | `C201265` | Timing Relative To/From | + +> These codes identify which CDISC CT *codelist* populates a dropdown's +> options — they are unrelated to `CDISC_API_KEY`/`CDISC_SUBSCRIPTION_KEY` +> (API credentials) or `CDISC_CONCEPTS_JSON` (Biomedical Concept overrides). + --- ## Start web server diff --git a/config.env b/config.env index 9dcbd56..e792af1 100644 --- a/config.env +++ b/config.env @@ -99,3 +99,32 @@ CDISC_REQUEST_TIMEOUT=15 # Set to 0 to disable eager population of biomedical concept # properties at startup (enables lazy loading instead). SOA_EAGER_BCP_POPULATION=1 + + +# ------------------------------------------------------------ +# CDISC Codelist Codes (Dropdowns) +# ------------------------------------------------------------ +# Each of these identifies the CDISC CT codelist whose terms +# populate a specific dropdown in the UI. Change a value to +# point that dropdown at an alternate/custom codelist. Changes +# require a server restart to take effect. + +CODELIST_EPOCH_TYPE=C99079 +CODELIST_ARM_TYPE=C174222 +CODELIST_ARM_DATA_ORIGIN_TYPE=C188727 +CODELIST_ROLE_TYPE=C215480 +CODELIST_ORGANIZATION_TYPE=C215480 +CODELIST_AMENDMENT_REASON=C207415 +CODELIST_AMENDMENT_IMPACT_TYPE=C215481 +CODELIST_GEOGRAPHIC_SCOPE_TYPE=C207412 +CODELIST_GOVERNANCE_DATE_TYPE=C207413 +CODELIST_STUDY_TITLE_TYPE=C207419 +CODELIST_INTERVENTION_ROLE=C207417 +CODELIST_INTERVENTION_TYPE=C99078 +CODELIST_INTERVENTION_UNIT=C66781 +CODELIST_OBJECTIVE_LEVEL=C188725 +CODELIST_ENDPOINT_LEVEL=C188726 +CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING=C127262 +CODELIST_ENCOUNTER_CONTACT_MODE=C171445 +CODELIST_TIMING_TYPE=C201264 +CODELIST_TIMING_RELATIVE_TO_FROM=C201265 diff --git a/docs/soa-workbench-improvement-plan.md b/docs/soa-workbench-improvement-plan.md new file mode 100644 index 0000000..3a12ee0 --- /dev/null +++ b/docs/soa-workbench-improvement-plan.md @@ -0,0 +1,219 @@ +# soa-workbench Improvement Plan + +## Context + +A full-codebase analysis (core Python, Claude agents/skills, MCP server) found that the +project is functionally healthy (~257 passing tests, clean pre-commit pipeline, active +DAIR feature work) but carries structural debt that slows every change: + +- **Oversized hotspots**: `app.py` (7,039 lines), `migrate_database.py` (3,319 lines / + 104 unversioned migrations run on every startup), `create_define_json.py` (4,505), + `amendments.py` (2,596), `utils.py` (1,848 with 8 copy-pasted TTL caches), + `audit.py` (939 with 40+ copy-pasted recorders that swallow exceptions). +- **Test gaps**: 10 routers have no tests, including the 1,377-line + `_freeze_helpers.py` that powers freeze/rollback. +- **MCP server** (`src/soa_builder/mcp/server.py`, 11 tools) covers ~8% of the 165+ + endpoint API: no freeze/rollback, no epoch/arm/element/instance CRUD, no audit + access, no DAIR/exports, no pagination; its write tools bypass the audit trail. +- **Claude config**: db-ops-reviewer agent memory asserts a "rogue `_connect()` in + freezes.py" that has since been fixed; usdm-soa-protocol-expert has empty memory; + three overlapping USDM experts lack routing guidance; skill frontmatter is + incomplete. + +User decisions: full structural refactor; high-value MCP workflow tools; agent/skill +work = stale-memory fixes + USDM routing clarity + a new DAIR report-writer skill +(no migration-advisor agent). + +All work happens on a new branch off `master` (not the active +`pi-add-impact-analysis-report` branch). Python commands use +`source .venv/bin/activate &&`. Never touch `soa_builder_web.db`; ad-hoc smoke tests +must set `SOA_BUILDER_DB=soa_builder_web_tests.db`. + +--- + +## Workstream A — Claude agents, skills & memory (small, do first) + +Low-risk documentation/config edits; restores trust in agent output before the agents +are used to review the refactor. + +1. **Fix db-ops-reviewer stale memory** + - `.claude/agent-memory/db-ops-reviewer/MEMORY.md` and `patterns.md`: remove the + freezes.py "rogue `_connect()` / module-level DB_PATH" claim (fixed in code — + `routers/freezes.py` now uses `from ..db import _connect`); re-verify the other + cited issues/line numbers against current code and update or delete. +2. **Initialize usdm-soa-protocol-expert memory** + - Create `.claude/agent-memory/usdm-soa-protocol-expert/MEMORY.md` seeded with the + recurring SoA→USDM mapping patterns already documented in the agent definition. +3. **Skill frontmatter fixes** + - `.claude/skills/code-review/SKILL.md`: add missing frontmatter fields to match + the other skills. + - `.claude/skills/run-soa-workbench/SKILL.md`: add `command` declaration. +4. **USDM routing guidance** + - Add a short "Which USDM expert to use" section to `CLAUDE.md` (or a shared note + linked from all three): usdm-sme skill = standard/spec questions; + usdm-implementation-expert agent = IG-v4 compliance/validation; + usdm-soa-protocol-expert agent = SoA mapping + live workbench data via MCP. + Cross-link the two project agents' MEMORY.md files. +5. **New skill: `dair-report-writer`** + - `.claude/skills/dair-report-writer/SKILL.md` encoding the DAIR conventions + established on the current branch: decode values instead of `Code_{n}`, + "snapshot" terminology (never "freeze" in report text), table header-row + repetition across page breaks, section 3.4/3.5 intent explanations, explanatory + paragraphs under section-2 subsections. Point it at + `src/usdm/generate_dair.py` and `routers/dair.py`. +6. **Refresh dated project memory** + - Re-verify `bcp_architecture.md` and `feedback_ncit_confidence.md` in the + project memory dir; update or annotate with verification date. + +## Workstream B — MCP server expansion & hardening + +File: `src/soa_builder/mcp/server.py` (raw MCP SDK, stdio, dispatch pattern); +tests: `tests/test_mcp_server.py`. Reuse the web layer's logic — do not duplicate +SQL: call into the same helpers routers use (e.g. `routers/_freeze_helpers.py`, +`usdm.generate_dair.build_dair`) where practical. + +1. **Quality fixes to existing tools (do first)** + - Route all 5 write tools through the audit recorders in `soa_builder/web/audit.py` + (same before/after pattern routers use). + - `assign_instance_activity`: validate `instance_id`/`activity_id` exist before + insert. + - `_create_activity`: remove the silent try/except fallback that drops + label/description; fail with a clear error. + - Add `limit`/`offset` params to `list_soas`, `list_visits`, `list_activities`. +2. **New workflow tools** (~15-20 tools, grouped; each with schema, FK validation, + audit integration, tests): + - **Freeze/rollback**: `list_freezes`, `create_freeze`, `rollback_freeze`, + `diff_freezes` (reuse `_freeze_helpers.py` — after Workstream C adds its + characterization tests). + - **Design entities**: CRUD for epochs, arms, elements, study cells + (mirror the router logic; keep UID generation identical). + - **Instances**: `create_instance`, `update_instance`, `delete_instance`. + - **Audit access**: `get_audit_history(soa_id, entity_type?, limit, offset)`. + - **Reports/exports**: `generate_dair(soa_id, base_freeze_id, revised_freeze_id)` + returning the DOCX path; `export_excel(soa_id)`. + - **Validation**: `validate_soa(soa_id)` wrapping the existing validation module. +3. **Error handling**: wrap sqlite constraint violations into structured error + messages; keep the ValueError-for-validation convention. + +## Workstream C — Structural refactor (phased; each phase lands green) + +Verified facts that shape the design: migrations run at **module import time** in +`app.py` (lines ~305–412: `_init_db()` + 104 bare calls), not in the lifespan; +`_connect` lives in `web/db.py` and is re-exported through `initialize_database.py` +into `app.py`; ~60 test files (and `usdm/generate_study_titles.py`) import from +`soa_builder.web.app`, so `app.py` must remain a permanent compat shim. Routers +avoid circular imports today via deferred `from ..app import ...` inside function +bodies. Each phase is its own branch/PR off `master`, merged sequentially. + +### Phase 0 — Characterization tests (pure test additions) +- `tests/test_freeze_helpers_characterization.py`: TestClient round-trips over + create SoA → populate → freeze → mutate → diff → rollback → preview; plus direct + unit tests for `_diff_entity_list` and representative `_capture_*` functions. +- Thin happy-path + 404 tests for the other 9 untested routers (mock `requests.get` + for the terminology ones, following `tests/test_fetch_sdtm_specializations.py`). +- **Golden schema test** (`tests/test_schema_snapshot.py`): full `sqlite_master` + inventory after fresh init vs checked-in snapshot — safety net for Phases 1/4. +- **Route-inventory test** (`tests/test_route_inventory.py`): `{(method, path)}` + set vs checked-in snapshot — safety net for Phases 3/5. + +### Phase 1 — Migration registry (hand-rolled, not Alembic) +Alembic is wrong here: app is raw `sqlite3` (no SQLAlchemy), and the 104 migrations +are imperative idempotent Python functions — a ~70-line registry preserves them +byte-for-byte. +- New `src/soa_builder/web/migrations/`: `registry.py` (ordered + `MIGRATIONS: list[tuple[name, callable]]` importing existing functions unchanged) + and `runner.py` (`run_pending_migrations()` with a + `schema_migrations(name PRIMARY KEY, applied_at)` table; skip recorded entries). +- **Baselining is free**: first boot runs all 104 (no-ops on up-to-date DBs, exactly + like every boot today) and records them; subsequent boots skip all. Idempotency + retained as safety net. +- In `app.py`: replace the 106-line import block + 104-call block with one + `run_pending_migrations()` call — kept at module import time (tests depend on + `import app` ⇒ DB ready). +- Convention forward: new migrations named `m0105_` in `migrations/`, + appended to the registry; `migrate_database.py` frozen. +- Accepted limitation (documented, not fixed): existing migration functions swallow + their own exceptions, so a failed migration can be recorded as applied — same + semantics as today, protected by idempotency. + +### Phase 2 — `CachedResource` + generic audit recorder +- New `src/soa_builder/web/caching.py`: `CachedResource` as a **`MutableMapping` + subclass** (existing code and tests poke the cache dicts directly with + `.update()`/`["data"]`, and tests mutate module-level instances in place — so the + 8 replacements keep the same names and dict compatibility). Methods: + `is_fresh(ttl)`, `store()`, `fail()`, `invalidate()`. Tighten `_get_ct_rows()` to + use it. +- Rewrite `audit.py` around one `_record_audit(table, entity_col, soa_id, action, + entity_id, before, after)` core + declarative per-table specs (irregular tables + like `reorder_audit` get explicit paths). All 33 `_record_*_audit` names stay as + thin wrappers with identical signatures; exact INSERT columns preserved. Keep the + intentional broad catch ("audit must never break the request") but log at + **error** level instead of warning. + +### Phase 3 — `app.py` split (three sub-PRs) +Target layout: `application.py` (FastAPI instance, mounts, include_router calls), +`bootstrap.py` (`_init_db()` + `run_pending_migrations()` at import), +`lifespan.py`, `templating.py`, `services/concepts.py` + `services/matrix.py` +(business logic), and four new routers for the ~90 inline endpoints: +`routers/soa_core.py`, `routers/exports.py`, `routers/concepts_admin.py`, +`routers/soa_ui.py` (no prefixes; registered in original order → identical URLs). +- **3a — services extraction**: move concept/matrix logic to `services/`; repoint + the deferred `from ..app import ...` in `routers/activities.py`, + `bc_categories.py`, `bc_surrogates.py`, `concept_groups.py`, `rollback.py`, + `_freeze_helpers.py` to top-of-file `..services.*` imports (circularity gone). +- **3b — endpoint extraction** into the four routers; route-inventory test proves + equivalence. +- **3c — composition root + permanent shim**: `app.py` becomes explicit re-exports + (`app`, `main`, `_connect`, `templates`, `fetch_biomedical_concepts`, caches, + etc. — final list grep-driven from `from soa_builder.web.app import` + + `from ..app import` across `src/` and `tests/`). Do NOT migrate the 60 test + files. `soa-builder-web = "soa_builder.web.app:main"` entry point untouched. +- Guard: services modules never import `application` at module level; check with + `python -c "from soa_builder.web.app import app, _connect"` and an + `/openapi.json` diff before/after. + +### Phase 4 — Split `migrate_database.py` by domain +Pure code move now that orchestration is in the registry: `migrations/legacy_core.py`, +`legacy_concepts.py`, `legacy_amendments.py`, `legacy_people_orgs.py`, +`legacy_terminology.py` (bodies unchanged); `migrate_database.py` becomes a +re-export shim (grep for direct test imports first). + +### Phase 5 — Shrink `amendments.py` / `activities.py`; split `_freeze_helpers.py` +File→package pattern with shared router instances: `routers/amendments/` with +`_shared.py` (`router`, `ui_router`, `templates`, UID/code helpers) + `crud.py`, +`components.py`, `scopes.py`, `ui.py`; `__init__.py` re-exports `router`/`ui_router` +so `application.py` imports and all URL paths stay identical. Same for +`routers/activities/` (`crud.py`, `concepts.py`, `dss.py`, `crf.py`, `ui.py`). +Split `_freeze_helpers.py` (now under Phase 0 tests) into +`routers/freeze_support/{capture,diff,rollback}.py` with `_freeze_helpers.py` as a +re-export shim (`usdm/` imports from it). +**Sequencing**: do this after `pi-add-impact-analysis-report` merges (that branch is +active in amendments/DAIR territory), or accept one mechanical rebase. + +### Phase 6 — Mechanical sweeps (last) +- Narrow the ~82 router `except Exception` clauses to `sqlite3.Error`, + `requests.RequestException`, `(KeyError, ValueError)` as evidence dictates; + explicitly keep broad catches in `audit.py`, `lifespan.py`, and migrations. One + commit per router; enable ruff `BLE001` at the end. +- Add return-type hints module-by-module; optionally enable ruff `ANN201` for + `src/soa_builder/web/`. +- Out of scope (flagged follow-up with its own characterization pass): + splitting `usdm/create_define_json.py` (4,505) and `generate_dair.py` (1,635) + beyond repointing their `app` imports in Phase 3. + +### Cross-workstream ordering +A (agent/skill fixes) → B.1 (MCP quality fixes) → C Phase 0 → C Phase 1 → C Phase 2 +→ B.2 freeze/audit MCP tools (needs Phase 0 freeze tests) → C Phases 3–4 → remaining +B.2 tools → C Phase 5 (after DAIR branch merges) → C Phase 6. + +## Verification + +- `source .venv/bin/activate && pytest` green after every phase/workstream step. +- `pre-commit run --all-files` (black/ruff + pytest) before each commit. +- Smoke test via `.claude/skills/run-soa-workbench` (`smoke.sh`, port 9877, 14 + checks) after app.py split and after MCP changes, with + `SOA_BUILDER_DB=soa_builder_web_tests.db`. +- MCP: extend `tests/test_mcp_server.py` (direct `_dispatch()` calls) for every new + tool; verify audit rows are written for MCP mutations. +- Migration registry: test against (a) a fresh empty DB and (b) a copy of an + existing fully-migrated DB (baseline path) — never the production DB itself. \ No newline at end of file diff --git a/docs/usdm-validation-h2q-mc-lzzt-20260618.md b/docs/usdm-validation-h2q-mc-lzzt-20260618.md new file mode 100644 index 0000000..f6c9696 --- /dev/null +++ b/docs/usdm-validation-h2q-mc-lzzt-20260618.md @@ -0,0 +1,137 @@ +# USDM Validation Report: H2Q-MC-LZZT-20260618T1509.json + +**File:** `output/json/H2Q-MC-LZZT-20260618T1509.json` +**USDM Version:** 4.0 +**Generator:** SOA Workbench v1.4.0 +**Validated:** 2026-06-23 +**Overall Confidence:** 73% + +--- + +## Entity Class Inventory + +47 entity classes present across ~7,074 total instances. Three expected classes are absent: + +| Missing Class | Severity | Notes | +|---|---|---| +| `EligibilityCriterion` | Critical | Required by USDM-IG §4.18 | +| `EligibilityCriterionItem` | Critical | Text carrier for criteria | +| `ScheduleTimelineExit` | Major | Required exit markers per §4.14 | +| `BiomedicalConceptCategory` | Minor | Grouping only; optional | +| `Range` | Minor | Needed for `plannedAge` | + +--- + +## Critical Findings (4) + +**C-01 · Eligibility criteria missing** +`InterventionalStudyDesign.eligibilityCriteria = []` and +`StudyVersion.eligibilityCriterionItems = []`. No eligibility criterion text exists +anywhere in the export. USDM-IG §4.18 requires each criterion to be referenced from +the study design population or its cohorts. + +**C-02 · Dangling foreign key on ScheduledDecisionInstance_2** +`defaultConditionId = "blahblahblah"` — no entity with that ID exists across all 27 +scheduled instances in the four timelines. The SDI also has zero `conditionAssignments`, +making it an inoperable decision node. This is a placeholder that was not cleaned up +before export. + +**C-03 · Study.id is null** +The root `Study` entity carries no identifier. USDM-IG §4.4 requires a UUID for global +uniqueness. All other entity IDs follow `{EntityName}_N` correctly. + +**C-04 · EligibilityCriterion / EligibilityCriterionItem entity classes entirely absent** +Consequence of C-01 — listed separately because the entity classes themselves are missing +from the output, not just empty arrays. + +--- + +## Major Findings (6) + +**M-01 · No ScheduleTimelineExit on any timeline** +All four `ScheduleTimeline.exits[] = []`. §4.14 requires exit markers linked from the +last SAI of each timeline. Zero SAIs have `timelineExitId` set. + +**M-02 · 7 of 40 activities (17.5%) linked to no ScheduledActivityInstance** +`Activity_34–40`: Adverse Events, Check Adverse Events, Patient Summary, Supine, +Vital Signs Supine, Stand, Vital Signs Standing — all orphaned with no timeline +assignment. + +**M-03 · studyType, studyPhase, blindingSchema all null** +For a randomized, double-blind, parallel 3-arm trial these are the primary +characterizing fields per §4.8. + +**M-04 · Organization_2 (ClinicalTrials.gov) has wrong type code** +Code C142578 = "Independent Data Monitoring Committee". Should be the clinical study +registry type code (C93453 or equivalent) per §4.7. + +**M-05 · StudyDesignPopulation missing criterionIds, plannedEnrollmentNumber, plannedAge** +Planned enrollment of ~300 is in the description string only. No `Range` entity encodes +an age window. + +**M-06 · StudyVersion.dateValues empty** +At least one approval/effective date at the version level is expected per §4.6. A single +`GovernanceDate` entity exists elsewhere in the document but is not wired here. + +--- + +## Minor Findings (5) + +| ID | Finding | +|---|---| +| N-01 | No `BiomedicalConceptCategory` groupings for 168 BCs (§4.13 recommends groupings: Vital Signs, Labs, Efficacy, Safety) | +| N-02 | `Range` entity absent entirely — direct consequence of M-05 | +| N-03 | `StudyVersion.rationale` and `StudyDesign.rationale` are empty strings `""` | +| N-04 | `StudyDesign.name = "Darren"` — developer placeholder; requires a meaningful value | +| N-05 | `abbreviations`, `narrativeContentItems`, `businessTherapeuticAreas` empty (all optional per schema) | + +--- + +## Passing Checks (9) + +| Check | Result | +|---|---| +| Wrapper shape (`usdmVersion`, `systemName`, `systemVersion`) | Pass | +| StudyCell matrix | Pass — perfect 3 arms × 5 epochs = 15 cells | +| Cross-reference integrity | Pass — zero dangling IDs (except C-02) | +| `mainTimeline` flag | Pass — exactly 1 of 4 timelines carries it | +| ScheduleTimeline `entryIds` | Pass — all resolve to valid SAI IDs | +| Entity UID format | Pass — all follow `{EntityName}_N` monotonic pattern | +| Global ID uniqueness | Pass — zero duplicates across ~7,074 instances | +| BiomedicalConcept-to-Activity linkage | Pass — 161 of 168 BCs linked | +| Code / AliasCode coverage | Pass — 1,276 codes, 994 aliases | + +--- + +## Confidence Breakdown + +| Dimension | Score | Notes | +|---|---|---| +| Schema validity | 95% | OpenAPI schema passes; no type/enum violations | +| Entity class completeness | 78% | 47/50 classes present; 3 missing (2 critical) | +| Cross-reference integrity | 90% | 1 dangling FK (C-02) in ~333 references | +| SoA schedule completeness | 82% | 7 orphan activities, no timeline exits | +| Regulatory metadata | 55% | Study.id null, eligibility absent, studyType null | +| **Overall** | **73%** | | + +The file is safe for internal development and SoA review. It is **not ready for +regulatory submission** without resolving C-01 through C-04. + +--- + +## Remediation Notes (Future Work) + +All fixes are generator-side in `src/usdm/`: + +| Priority | Generator | Fix | +|---|---|---| +| 1 | `generate_studydesign.py` | Wire `eligibilityCriteria` from DB | +| 1 | `generate_studyversion.py` | Wire `eligibilityCriterionItems`; assign UUID to `Study.id` | +| 1 | `generate_schedule_timeline.py` | Fix `ScheduledDecisionInstance_2.defaultConditionId` | +| 2 | `generate_schedule_timeline.py` | Add `ScheduleTimelineExit` per timeline | +| 2 | SoA DB / activities | Investigate 7 orphaned activities | +| 2 | `generate_studydesign.py` | Populate `studyType`, `studyPhase`, `blindingSchema` | +| 2 | `generate_organizations.py` | Correct ClinicalTrials.gov type code to C93453 | +| 2 | `generate_studydesign_population.py` | Add `plannedEnrollmentNumber` and `Range` for age | +| 3 | `StudyDesign.name` | Replace "Darren" placeholder | +| 3 | `rationale` fields | Populate from protocol synopsis | diff --git a/docs/usdm-validation-nct01797120-20260618.md b/docs/usdm-validation-nct01797120-20260618.md new file mode 100644 index 0000000..eab6a83 --- /dev/null +++ b/docs/usdm-validation-nct01797120-20260618.md @@ -0,0 +1,197 @@ +# USDM Validation Report: NCT01797120-20260618T1511.json + +**File:** `output/json/NCT01797120-20260618T1511.json` +**Study:** PrE0102 — Phase II HR+ Metastatic Breast Cancer (Fulvestrant ± Everolimus) +**USDM Version:** 4.0 +**Generator:** SOA Workbench v1.4.0 +**Validated:** 2026-06-23 +**Overall Confidence:** 52% + +This export is a **skeleton SoA** — the study structure is partially defined but the +schedule matrix has no procedural content (no activities linked to any visit instance, +no timing windows). Not suitable for regulatory submission or SDTM derivation. + +--- + +## Entity Class Inventory + +35 entity classes present across ~1,286 total instances (vs. ~7,074 for H2Q-MC-LZZT). +Notable: `Estimand` (6) and `IntercurrentEvent` (15) are populated; `StudyAmendment` is not. + +| Missing Class | Severity | Notes | +|---|---|---| +| `EligibilityCriterion` | Critical | Required by USDM-IG §4.18 | +| `EligibilityCriterionItem` | Critical | Text carrier for criteria | +| `ScheduleTimelineExit` | Critical | Required exit per §4.14 | +| `StudyAmendment` | Info | None recorded for this version | +| `ScheduledDecisionInstance` | Info | No branching logic in this design | +| `BiomedicalConceptCategory` | Minor | Optional groupings | +| `Range` | Major | Needed for `plannedAge`, `plannedEnrollmentNumber` | + +--- + +## Critical Findings (8) + +**C-01 · Study.id is null** +The root `Study` entity carries no identifier. USDM-IG §4.4/§6.3 require a UUID for +global uniqueness and SDR primary key use. All other entity IDs follow `{EntityName}_N` +correctly. + +**C-02 · studyType, studyPhase, blindingSchema all null; model Code is empty** +For a randomized, double-blind, parallel 2-arm Phase II trial these are required +characterizing fields per §4.8. Expected values: +- `studyType` → `{code=C93988, decode=INTERVENTIONAL}` +- `studyPhase` → `{code=C15602, decode=PHASE II TRIAL}` +- `blindingSchema` → `{code=C49660, decode=DOUBLE BLIND}` +- `model.code/decode` → `{code=C82639, decode=PARALLEL}` + +**C-03 · EligibilityCriteria entirely absent** +`InterventionalStudyDesign.eligibilityCriteria = []`, +`StudyVersion.eligibilityCriterionItems = []`, +`StudyDesignPopulation.eligibilityCriteriaId = null`. +PrE0102 has well-defined inclusion/exclusion criteria. Required for SDTM IE domain +mapping per §4.18 and §7.1. + +**C-04 · ScheduleTimelineExit absent** +`ScheduleTimeline_1.exits = []`. Per §4.14 a timeline requires 1..* exits. +Without an exit the timeline is topologically open. + +**C-05 · Dangling foreign key: ScheduledActivityInstance_3.defaultConditionId = "ScheduledActivityInstance_4"** +No instance with ID `ScheduledActivityInstance_4` exists in the timeline. +Instance IDs present: 1, 2, 3, 6, 7, 8, 9, 10, 11. The sequence chain breaks at +C1D15 — the next scheduled visit cannot be resolved. + +**C-06 · All 9 ScheduledActivityInstances have activityIds = []** +No activities are linked to any visit instance. The entire SoA matrix has topology but +no procedural content. This is the most significant completeness gap in this export. + +**C-07 · StudyVersion.dateValues is empty** +No protocol approval or study start date at the version level. Required for SDR +provenance per §4.6. + +**C-08 · Encounter_1.scheduledAtId references Timing_1 which does not exist** +`studyDesignTimings = []` at the design level — no `Timing` objects exist — yet +`Encounter_1` references one. This is a dangling FK at the schedule entry point. + +--- + +## Major Findings (10) + +**M-01 · All 12 StudyRole instances have organizationId=null and personId=null** +Role codes are present but the links to organizations and persons are broken. Breaks +§6.3 API Required Content rule (sponsor role must scope the sponsor identifier). + +**M-02 · StudyDesignPopulation has no populated fields** +`description`, `plannedEnrollmentNumber`, `plannedAge`, `plannedSex=[]`, +`criterionIds=[]` all null/empty. PrE0102 targets ~120 post-menopausal women. + +**M-03 · StudyEpoch_4 (Continuation Phase) has no StudyCells** +2 arms × 4 epochs = 8 cells required; only 6 exist. The Continuation Phase epoch is +referenced in the epoch chain but excluded from the StudyCell matrix. + +**M-04 · studyDesignTimings = [] — no Timing objects at design level** +No visit days, cycle lengths, or windows encoded in the schedule. (One `Timing` +instance exists elsewhere but is not wired into the design timings list.) + +**M-05 · All 4 StudyElement.studyInterventionIds = []** +Treatment elements not linked to interventions; SDTM TE domain generation will fail. + +**M-06 · All 6 Estimand.treatmentId = null; both StudyIntervention.codes = []** +The treatment being estimated is unspecified. No ATC/UNII codes for Fulvestrant or +Everolimus. + +**M-07 · All 14 BiomedicalConceptSurrogate have bcId=null and activityId=null** +Surrogates are defined but all reverse links are broken. + +**M-08 · All 5 Organization.identifier and identifierScheme are empty strings** +Per §4.9/§6.3, organizations must carry DUNS or equivalent identifiers. + +**M-09 · ScheduledActivityInstance_10 ("RANDOMIZE") has encounterId=null** +The randomization step cannot be placed in the SoA timeline. + +**M-10 · 16 of 22 activities (73%) have no BC or BCSurrogate assignment** +50 BiomedicalConcepts are defined in the export but most are not linked back to +activities. + +--- + +## Minor Findings (5) + +| ID | Finding | +|---|---| +| N-01 | `Objective.text` empty for both objectives; `Endpoint.text` empty for all 6 endpoints | +| N-02 | All 6 `Estimand.summaryMeasure = null` (e.g., "Hazard Ratio", "Median PFS") | +| N-03 | Some `Code.decode` fields equal the bare code string rather than the CT preferred term | +| N-04 | `ScheduleTimeline.entryCondition=null`, `plannedDuration=null` | +| N-05 | Typo: `Encounter_8.description = "Foolow-up"` instead of "Follow-up" | + +--- + +## Passing Checks (9) + +| Check | Result | +|---|---| +| Wrapper shape (`usdmVersion="4.0"`, `systemName`, `systemVersion`) | Pass | +| `instanceType` on all entities | Pass | +| StudyCell cross-references (armId, epochId) | Pass — all 6 resolve | +| StudyArm type codes (CDISC CT) | Pass | +| StudyEpoch codes (SDTM CT) | Pass | +| Organization type codes | Pass | +| Indication coded with NCIt | Pass | +| Encounter linked-list chain | Pass — all 8 encounters linked | +| StudyEpoch chain | Pass — 4 epochs linked (order: 1→2→4→3) | + +--- + +## Confidence Breakdown + +| Dimension | Score | Notes | +|---|---|---| +| Schema validity | 65% | Null required fields, empty model Code, dangling FK | +| Entity class completeness | 83% | 35/42 expected classes; 3 critical missing | +| Cross-reference integrity | 72% | SAI_3→SAI_4 broken; Encounter_1→Timing_1 broken; all StudyRoles unlinked | +| SoA schedule completeness | 25% | All 22 activities orphaned; no Timing objects wired | +| Regulatory metadata | 30% | Study.id null; eligibility absent; studyType/phase/blinding null; dateValues empty | +| **Overall** | **52%** | | + +--- + +## Comparison with H2Q-MC-LZZT (same generator version) + +| Dimension | H2Q-MC-LZZT | NCT01797120 | +|---|---|---| +| Overall confidence | 73% | 52% | +| Activities linked to SAIs | 33/40 (82%) | 0/22 (0%) | +| Timing objects | 24 | 0 (wired) | +| studyType/studyPhase/blinding | null | null | +| Study.id | null | null | +| Eligibility criteria | absent | absent | +| ScheduleTimelineExit | absent | absent | +| studyDesign.name | "Darren" (placeholder) | valid | +| Dangling FK | SDI_2 defaultConditionId | SAI_3 defaultConditionId | + +The `Study.id` null, eligibility absent, `studyType`/`studyPhase` null, and +`ScheduleTimelineExit` absent appear to be **systemic generator-level gaps** common +to both exports. The zero activity-to-instance linkage in this export is an additional +data-entry gap specific to this SoA. + +--- + +## Remediation Notes (Future Work) + +All systemic fixes shared with H2Q-MC-LZZT are already logged in +`docs/usdm-validation-h2q-mc-lzzt-20260618.md`. Additional items specific to this study: + +| Priority | Fix | +|---|---| +| 1 | Wire `activityIds` on all `ScheduledActivityInstance` entries | +| 1 | Fix `ScheduledActivityInstance_3.defaultConditionId` (SAI_4 does not exist) | +| 1 | Add `Timing` objects and wire to `studyDesignTimings` and `Encounter.scheduledAtId` | +| 2 | Add `StudyCell` for `StudyEpoch_4` (Continuation Phase) × both arms | +| 2 | Populate `StudyRole.organizationId` and `personId` | +| 2 | Add `Organization.identifier` / `identifierScheme` (DUNS/ROR) | +| 2 | Link `StudyElement.studyInterventionIds` → `StudyIntervention` | +| 2 | Set `Estimand.treatmentId`; add ATC/UNII codes to `StudyIntervention.codes` | +| 2 | Populate `Objective.text` and `Endpoint.text` | +| 3 | Fix typo `Encounter_8.description` ("Foolow-up") | +| 3 | Set `Estimand.summaryMeasure` for all 6 estimands | diff --git a/files/Digital_Amendment_Impact_Report_DAIR.docx b/files/Digital_Amendment_Impact_Report_DAIR.docx new file mode 100644 index 0000000..2263156 Binary files /dev/null and b/files/Digital_Amendment_Impact_Report_DAIR.docx differ diff --git a/files/NCT01797120_protocol_text.txt b/files/NCT01797120_protocol_text.txt new file mode 100644 index 0000000..6219fcd --- /dev/null +++ b/files/NCT01797120_protocol_text.txt @@ -0,0 +1,6266 @@ +PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +1 + +Introduction + +1.1 + +Background and Rationale + +Endocrine therapy represents the foundation of treatment for hormone-receptor +positive metastatic and locally advanced breast cancer. Multiple compounds in +varying classes exist, and those most widely used include the selective estrogen +receptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen +receptor down-regulators (SERDs). Although the utility of these drugs is well +established, as many as 50% of women with hormone-receptor positive breast cancer +will fail to respond to endocrine treatment (de novo resistance). Moreover, those who +do respond will inevitably develop acquired resistance.1 Resistance to endocrine +therapy remains a serious clinical challenge. +Basic scientific research into the mechanisms surrounding endocrine therapy +resistance has been particularly intense in recent years. Advances in this area of +investigation are driving the development of novel treatments and therapeutic +strategies. For example, various signal transduction pathways, when activated, have +been demonstrated to allow breast cancer cells to escape the effect of endocrine +therapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase +signaling pathway appears to play a vital role in drug resistance.2 Several studies +identify a close association between aberrant Akt signaling and tamoxifen resistance.3 +High levels of Akt activity confer resistance to the aromatase inhibitor letrozole and +the selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced +resistance does not appear to be secondary to failure of these agents to inhibit the +estrogen receptor α activity, but instead may lead to altered cell cycle and apoptotic +response.5 Clinically, Akt/PKB activation in breast cancer appears to predict an +inferior outcome among patients treated with endocrine therapy.6 +mTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a +central regulator of many biological processes involved in cellular proliferation, +angiogenesis and metabolism. mTOR is a key protein involved in control and +regulation of the cell’s translational machinery through multiple mechanisms including +by directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point +of convergence for a number of cellular signaling pathways, including Akt/PKB.8 +mTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has +emerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR +activity has been shown to restore tamoxifen response in breast cancer cells with +aberrant Akt activity.9 +Everolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination +treatment with everolimus and either letrozole or fulvestrant has been shown to +reverse Akt-mediated endocrine therapy resistance and restore responsiveness to +anti-estrogens in preclinical studies.5 These observations formed the rationale leading +to the Phase I clinical trial evaluating the combination of everolimus and letrozole in +women previously treated with letrozole ≥ 4 months without objective response (e.g., +stable or progressive disease). Eighteen postmenopausal female patients with +advanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus +at 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well +tolerated and toxicities were manageable and consistent with that expected for +23 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +everolimus monotherapy. The results suggest antitumor activity for this combination +without Pharmacokinetic (PK) interactions. +This study will examine the efficacy and tolerability of the combination of fulvestrant +and everolimus for the treatment of postmenopausal metastatic breast cancer +resistant to an aromatase inhibitor. + +1.2 + +Breast Cancer + +Breast cancer is the most commonly diagnosed malignancy in women worldwide. In +the United States, an estimated 230,480 new cases of invasive breast cancer were +diagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances +in breast cancer therapy, 40-80% of women with node-positive disease and up to +30% of women with node-negative disease at diagnosis will relapse. When distant +metastases occur, the prognosis remains poor with a median survival of 18 to 36 +months from time of recurrence. Among the 60-70% of women with hormone-receptor +positive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine +therapy has shown to yield similar survival rates in hormone-sensitive disease as +compared to chemotherapy; although response rates are lower and responses +develop more slowly. Endocrine therapy is considerably less toxic than +chemotherapy, and is therefore the preferred treatment option for patients with +hormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in +HR-negative disease, in cases unresponsive to endocrine therapy, or when extensive +metastases require rapid tumor response.14 + +1.3 + +Endocrine Therapy for Breast Cancer + +Several endocrine therapies are available for the treatment of metastatic breast +cancer in postmenopausal women, including selective estrogen-receptor modulators +(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the +selective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen +was generally regarded as a standard option in HR-positive disease for adjuvant +therapy, and for first-line therapy of metastatic disease in postmenopausal women. +Within the past decade, however, the AIs (letrozole, anastrozole, exemestane) have +supplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic +disease in postmenopausal women.15,16 There is therefore a need to develop more +effective endocrine therapies for patients with AI-resistant disease, and to enhance +the effectiveness of existing endocrine therapies that have demonstrated efficacy in +AI-resistant disease. + +1.3.1 + +Fulvestrant for Post Menopausal Women with Breast Cancer + +Fulvestrant (Faslodex®, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has +several unique characteristics. It is the first drug which acts as a pure estrogen +receptor (ER) antagonist without known agonist effects. It competitively binds to the +ERs with an approximately 100 times greater affinity than that of tamoxifen. +Fulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were +performed in postmenopausal women with HR-positive metastatic breast cancer who +had progressive disease after tamoxifen therapy. These trials compared fulvestrant +24 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The +primary endpoint for both studies was time to disease progression (TTP), which was +similar between the two treatment arms (5.4 versus 3.4 months in the North American +trial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were +also comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5% +for anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for +anastrozole), median duration of response was 15-19 months (versus 11-15 months +for anastrozole), and median time to disease progression (TTP) was 5.5 months +(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the +clinical activity of fulvestrant in both visceral and non-visceral metastatic disease as +compared with anastrozole.19 These trials led to the approval of Faslodex® +(fulvestrant) Injection for “…the treatment of hormone-receptor positive metastatic +breast cancer in postmenopausal women with disease progression following +antiestrogen therapy”. +Table 1-0 +Phase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer +North American Trial + +18 + +19 + +European Trial + +Treatment Group: + +Fulvestrant + +Anastrozole + +Fulvestrant + +Anastrozole + +No. of Patients: + +206 + +194 + +222 + +229 + +Overall RR (%): + +17.5 + +17.5 + +20.7 + +15.7 + +CR (%): + +4.9 + +3.6 + +4.5 + +1.7 + +PR (%): + +12.6 + +13.9 + +16.2 + +14.0 + +42.2 + +36.1 + +44.6 + +45.0 + +24.8 + +18.6 + +23.9 + +29.3 + +Median TTP (months): + +5.4 + +3.4 + +5.5 + +5.1 + +Median Duration of Response +(months): + +19.0 + +10.8 + +15.0 + +14.5 + +Withdrawal Rate (%): + +2.5 + +2.6 + +3.2 + +1.3 + +Clinical Benefit Rate (%): +SD for more than 24 weeks (%): + +Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III +trial that included 587 postmenopausal women with HR-positive metastatic breast +cancer, but proved to be no more effective than tamoxifen in this setting.20 When +comparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%) +and clinical benefit rate (57% versus 62%) were similar. + +1.3.2 + +Fulvestrant for Aromatase Inhibitor (AI) Resistant Disease + +Several trials have evaluated the role of fulvestrant in AI-resistant disease, as +summarized in Table 1-1. + +25 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Table 1-1 +Phase II or III Trial of Fulvestrant in AI-Resistant Disease +Reference +Ingle, 2006 + +Treatment + +No. + +RR + +CBR + +Median TTP + +21 + +Fulvestrant + +77 + +14% + +25% + +3.0 mo. + +22 + +Fulvestrant + +20 + +5% + +37% + +3.5 mo. + +Fulvestrant + +270 + +7% + +23% + +3.7 mo. + +Exemestane + +270 + +7% + +19% + +3.7 mo. + +Perey, 2007 + +23 + +Chia, 2008 + +The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately +20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by +Chia et al, patients who had progressive disease after treatment with a non-steroidal +AI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase +inhibitor exemestane. In contrast to most other trials that utilized a single 250 mg +monthly dose based upon the original pharmacokinetic studies,23 patients in the +EFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28 +(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule +may more rapidly achieve therapeutic blood levels. There was no significant +difference in CBR between the two treatment arms. Nevertheless, the EFECT trial +confirmed the effectiveness of fulvestrant previously reported in other smaller trials of +fulvestrant in AI-resistant disease. +Previous trials had demonstrated that a dose of 125 mg was less effective than the +250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than +the 250 mg monthly dose may produce greater clinical benefit, several trials +evaluated alternative dosing schedules (similar to that used in the EFECT trial), +including FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM +(NCT00099437). + +1.3.3 + +Rationale for Fulvestrant for this Trial + +Fulvestrant has demonstrated activity when used as first, second, or third line +endocrine therapy, making it an attractive therapy for combination with other agents. +In addition, it is commonly reserved for use following disease progression on AI +therapy. The loading dose schedule employed in the EFECT trial will be used in this +study taking advantage of the known dose-response effect observed for fulvestrant, +the more rapid achievement of therapeutic blood levels, the extensive efficacy and +safety experience with this schedule, and because it appears to be emerging as the +preferred schedule for fulvestrant based upon the results of ongoing and recently +completed clinical trials. +The recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every +28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and +every 28 days thereafter (the current FDA-approved dose).24 The study demonstrated +that the higher dose was more effective. Median time to progression (TTP) was 6.5 +months with the higher dose compared with 5.5 months with the lower dose (HR 0.8, +p=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low +dose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had + +26 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +relapsed/progressed on an aromatase inhibitor (the population targeted in this study), +median TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard +arm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose +regimen as utilized in the CONFIRM trial.24 + +1.4 + +Everolimus (RAD001) + +Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR +inhibitor. +Everolimus has been in clinical development since 1996 as an immunosuppressant in +solid organ transplantation. Everolimus is approved in Europe and other global +markets (trade name: Certican®) for cardiac and renal transplantation, and in the +United States (trade name: Zortress®) for the prevention of organ rejection of kidney +transplantation. +Everolimus was developed in oncology as Afinitor® and was approved for advanced +renal cell carcinoma (RCC) in 2009. In 2010, Afinitor® received United States (US) +approval for patients with subependymal giant cell astrocytoma (SEGA) associated +with tuberous sclerosis (TS). Everolimus is also available as Votubia® in the +European Union (EU) for patients with SEGA associated with TS. Afinitor® was +approved for “progressive pancreatic neuroendocrine tumor (PNET) in patients with +unresectable, locally advanced, or metastatic disease” in 2011 in various countries, +including the US and Europe. +In 2012 Afinitor® received approval for the treatment of postmenopausal women with +advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ +BC) in combination with exemestane, after failure of treatment with letrozole or +anastrozole. Furthermore in 2012, Afinitor® received approval for the treatment of +patients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not +requiring immediate surgery. +Everolimus is being investigated as an anticancer agent based on its potential to act: +• + +Directly on the tumor cells by inhibiting tumor cell growth and proliferation. + +• + +Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via +potent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced +proliferation of endothelial cells). The role of angiogenesis in the maintenance of +solid tumor growth is well established, and the mTOR pathway has been +implicated in the regulation of tumor production of proangiogenic factors as well +as modulation of VEGFR signaling in endothelial cells. + +At weekly and daily schedules and at various doses explored, everolimus is generally +well tolerated. The most frequent adverse events (rash, mucositis, fatigue and +headache) associated with everolimus therapy are manageable. Non-infectious +pneumonitis has been reported with mTOR inhibitors but is commonly low-grade and +reversible. + +1.4.1 + +mTOR Pathway and Mechanism of Action + +At cellular and molecular levels, everolimus acts as a signal transduction inhibitor. +Everolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically +27 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly +conserved serine-threonine kinase which is present in all cells and is a central +regulator of protein synthesis and ultimately cell growth, cell proliferation, +angiogenesis and cell survival. mTOR is the only currently known target of +everolimus.25 +mTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in +a wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative +regulator; through PI3K mutation/amplification; through AKT/PKB overexpression/ +overactivation; through modulation of TSC1/TSC2 tumor suppressors). In addition, +activation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis +through increased aggressiveness, resistance to treatment and progression. +The main known functions of mTOR include the following:7,25 +• +• +• + +• +• + +mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient +levels, facilitating cell-cycle progression from G1 to S phase in appropriate growth +conditions. +The PI3K-mTOR pathway itself is frequently activated in many human cancers, +and oncogenic transformation may sensitize tumor cells to mTOR inhibitors. +Through inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and +activating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein +translation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to +decreased expression of HIF-1. +The activation of mTOR pathway is involved in the production of pro-angiogenic +factors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation. +The regulation of mTOR signaling is complex and involves positive regulators, +such as AKT that phosphorylate and inactivate negative regulators such as the +Tuberous Sclerosis Complex (TSC1/TSC2). + +mTOR is represented by two structurally and functionally distinct multiprotein +signaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and +mTORC2 (mTOR complex 2, rapamycin insensitive).26 +mTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as +PKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated +AKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex, +thus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows +Rheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1. +AKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the +PRAS40-mediated inhibition of mTORC1.27,28 +mTORC2 (mTOR complex 2) is activated through a currently unknown mechanism, +possibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that +mTORC2 phosphorylates and activates a different pool of AKT that is not upstream of +mTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is +rapamycin insensitive and is required for the organization of the actin cytoskeleton.26 +mTORC1-mediated signaling is subject to modulation by the macrocyclic lactone +rapamycin and its derivatives, such as everolimus. Once these agents bind to the 12 +kDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and +28 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +inhibit phosphorylation of mTOR substrates. As a consequence, downstream +signaling events involved in regulation of the G1 to S-phase transition are inhibited. +This mechanism is thought to be responsible for the immunosuppressive effects of +rapamycin as well as its putative antineoplastic activity.29 As many cancers are +characterized by dysregulation of G1 transit (for example, overexpression of cyclin or +cyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for +inducing cytostasis.7 +1.4.1.1 + +Preclinical Studies + +Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation +of cells. The only currently known target of everolimus is mTOR, a key regulatory +protein affecting cell growth.25 Everolimus exerts its activity through high affinity +interaction with an intracellular receptor protein, the immunophilin FKBP12. The +FKBP12/everolimus complex subsequently interacts with the mTOR protein kinase, +inhibiting downstream signaling events involved in regulation of the G1 to S-phase +transition. +The main known functions of mTOR include: +• + +Function as a sensor of mitogens, growth factors, energy and nutrient levels, +facilitating cell-cycle progression from G1 - S phase in appropriate growth +conditions. + +• + +Regulation of protein synthesis important for tumor cell proliferation and +angiogenesis through inactivating eukaryotic initiation factor 4E binding proteins +and activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example, +activation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth +muscle cell growth and proliferation. + +The PI3K-mTOR pathway itself is frequently activated in many human cancers, and +oncogenic transformation may sensitize tumor cells to mTOR inhibitors. The +regulation of mTOR signaling is complex and involves positive regulators such as +AKT that phosphorylate and inactivate negative regulators such as the Tuberous +Sclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions; +hence, the activities of everolimus may vary depending upon cell type. +The mTOR inhibitory activities presumably contribute to the anti-proliferative activity +of everolimus against tumor cell lines. However, everolimus may also exert an +antitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and +everolimus potently inhibit proliferation of endothelial cells and have antiangiogenic +activity in vivo.30,31 Exactly which molecular determinants predict responsiveness of +tumor cells to everolimus is still unclear. Currently, the activation status of the +PI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to +rapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation +of AKT has been suggested to sensitize tumors to the effects of inhibition of +mTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in +baseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient +population more likely to derive benefit from mTOR inhibition.32 + +29 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity +binding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar +potency of rapamycin and everolimus was also demonstrated at forming the mTOR/ +FKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory +activity against 10 other protein kinases at concentrations up to 10 μM. +The anti-proliferative effects of everolimus were investigated in a mixed panel of 48 +different tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung, +melanoma, prostate and renal). The majority of tumor cell lines were highly sensitive +to the anti-proliferative effects of everolimus while a few others appeared intrinsically +insensitive, or ‘resistant’ (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the +48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34 +Everolimus was also shown to have activity in human pancreatic neuroendocrine +cells, where induction of apoptosis was reported,35 as well as in acute myeloid +leukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse +large B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and +hepatocellular carcinoma cells.42 +Everolimus was also evaluated in a clonogenic assay using cells derived from 81 +patient derived tumor xenografts never cultured in vitro (11 human tumor types with 3 +to 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC), +Small Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and +pleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells +were found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher +than the tumor lines. +Everolimus was effective and well tolerated against subcutaneous (s.c.) tumors +established from a variety of tumor cell lines of diverse histotypes (NSCLC, +pancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of +reduction of tumor growth rates rather than producing regressions or stable disease +although, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors, +regressions could be obtained. These effects occurred within the dose range of 2.5 to +10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice +divided by the change in tumor volume of control mice (T/C) typically ranged from +approximately 15 to 50% at optimal doses. A marked loss of antitumor activity +occurred when tumor-bearing mice were treated with everolimus once per week, but +improved moderately with twice per week dosing. Antitumor activity of everolimus has +also been demonstrated in mouse models of ovarian,31 breast,43,44 and +gastrointestinal stromal tumors.45 + +1.4.2 + +Pre-Clinical Safety + +In safety pharmacology studies, everolimus was devoid of relevant effects on vital +organ functions including the cardiovascular, respiratory and nervous systems. +Everolimus had no effects on QT interval. Furthermore, everolimus showed no +antigenic potential. Although everolimus passes the blood-brain barrier, there was no +indication of relevant changes in the behavior of rodents, even after single oral doses +up to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day. +30 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +The preclinical safety profile of everolimus was assessed in mice, rats, minipigs, +monkeys, and rabbits. The major target organs were male and female reproductive +systems (testicular tubular degeneration, reduced sperm content in epididymides and +uterine atrophy) in several species; lungs (increased alveolar macrophages) in rats +and mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney +changes were seen in the rat (exacerbation of age-related lipofuscin in tubular +epithelium, increases in hydronephrosis) and mouse (exacerbation of background +lesions). There was no indication of kidney toxicity in monkeys or minipigs. +Genotoxicity studies covering relevant genotoxicity endpoints showed no evidence of +clastogenic or mutagenic activity. Administration of everolimus for up to 2 years did +not indicate any oncogenic potential in mice and rats up to the highest doses, +corresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In +reproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and +was considered potentially teratogenic in rats. It is therefore recommended that +women of childbearing potential should use effective contraceptive measures during +the entire treatment period and for 8 weeks thereafter. +More pre-clinical information is provided in the Investigator’s Brochure. + +1.4.3 +1.4.3.1 + +Clinical Experience + +Everolimus Pharmacokinetics + +Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state +AUC0-τ is dose-proportional over the dose range between 5 to 70 mg in the weekly +regimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two +weeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg +for both the weekly and daily regimens. At doses of 20 mg/week and higher, the +increase in Cmax is less than dose proportional. In healthy subjects, high fat meals +reduced systemic exposure to everolimus 10 mg (as measured by Area Under the +Concentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax +by 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had +no apparent effect on the post absorption phase concentration-time profile. +The blood-to-plasma ratio of everolimus, which is concentration-dependent over the +range of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the +plasma is approximately 20% at blood concentrations observed in cancer patients +given everolimus 10 mg/day. Plasma protein binding is approximately 74% both in +healthy subjects and in patients with moderate hepatic impairment. +Everolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP. +Following oral administration, everolimus is the main circulating component in human +blood and is considered to contribute the majority of the overall pharmacologic +activity. No specific excretion studies have been undertaken in cancer patients; +however, data available from the transplantation setting found the drug to be mainly +eliminated through the feces. There was a significant correlation between AUC0-τ and +pre-dose trough concentration at steady-state on the daily regimen. The mean +elimination half-life of everolimus is approximately 30 hours. +Appendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers. + +31 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4 +inhibitors/inducers and other medications. +More information on everolimus pharmacokinetics is provided in the Investigator’s +Brochure. +1.4.3.2 + +Everolimus Pharmacodynamic Studies + +Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker +p70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that +5-10 mg daily should be an adequate dose to produce a high-degree of sustained +target inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were +evaluated through serial biopsy before and during treatment. Biopsy on treatment +took place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on +Day 4 or 5 of the same week. Molecular activity was measured by +immunohistochemistry. In the absence of a reliable technique for measuring mTOR +phosphorylation, the phosphorylation status of downstream markers S6 and eIF4G, +for which reliable antibodies exist, was selected as reflecting the immediate +pharmacodynamic effect of everolimus. Also measured were changes in the +phosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five +patients were treated and the results revealed a dose and schedule dependent +inhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at +the 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of +the treated tumors. In the daily schedule, there was a correlation between everolimus +plasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was +good concordance of mTOR pathway inhibition between skin and tumor. [Study +C2107].47 +More information on everolimus pharmacodynamics is provided in the Investigator’s +Brochure (IB). +1.4.3.3 + +Clinical Experience with Everolimus + +Everolimus has been in clinical development since 1996 as an immunosuppressant in +solid organ transplantation and was approved in Europe in 2003 under the trade +name Certican®, for the prevention of organ rejection in patients with renal and +cardiac transplantation. It is also approved in the United States (trade name: +Zortress®) for the prevention of organ rejection of kidney transplantation. Additional +non-oncologic indications currently being explored are wet age-related macular +degeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD). +Clinical experience of everolimus in the transplant indication is summarized in a +separate Investigator’s Brochure. +In oncology, everolimus has been in clinical development since 2002 for patients with +various hematologic and non-hematologic malignancies as a single agent or in +combination with antitumor agents. Please note that safety pharmacology and +toxicology studies as well as some human pharmacology studies which have been +conducted in support of the transplant indication, are described in the oncology IB +due to the relevance of these data for the oncology indication. Malignancies that are +currently being evaluated in Novartis sponsored studies include the following: +32 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic +neuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell +lymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In +addition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated +subependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being +evaluated. Colorectal cancer (CRC) is no longer being evaluated. +Everolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name +Afinitor® for patients with advanced renal cell carcinoma in the US, EU and several +other countries and is undergoing registration in other regions worldwide. Recent +approval was granted in the US for the treatment of patients with subependymal giant +cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require +therapeutic intervention but are not candidates for curative surgical resection. +Phase I dose escalating studies, exploratory Phase I/II studies with everolimus as +single agent or in combination with other anti-cancer agents, Phase II/III studies of +everolimus in indications, and Phase III double-blind studies are contributing to the +extensive database. +Approximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011: +• +• +• +• + +9,528 patients in Novartis-sponsored clinical trials +2,559 patients in the individual patient supply program +6,638 in investigator-sponsored studies. +In addition, healthy volunteer subjects have participated in the clinical +pharmacology studies as described in Section 1.4.3.1. + +As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications +mRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer +(1) and HCC (1). +Recent approvals of everolimus (Afinitor®) were based upon a Phase III, international, +multicenter randomized, double-blind, placebo-controlled study [C2240] in patients +with metastatic renal cell carcinoma (mRCC) whose disease had progressed despite +prior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine +kinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded, +independent central review, was the primary endpoint. Secondary endpoints included +safety and objective tumor response. +In the pivotal, Phase III study [C2240], which included patients with advanced renal +cell carcinoma, the most common adverse reactions (incidence ≥ 10%) were +stomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation, +vomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis, +pruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence ≥ +2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis +is a class effect of rapamycin derivatives, including everolimus and some of these +cases have been severe and on rare occasions, fatal outcomes have been observed. +Everolimus has immunosuppressive properties and may predispose patients to +bacterial, fungal, viral or protozoan infections, including infections with opportunistic +pathogens. Localized and systemic infections, including pneumonia, other bacterial +infections, invasive fungal infections, such as aspergillosis or candidiasis and viral +33 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +infections including reactivation of hepatitis B virus, have been described in patients +taking everolimus. Some of these infections have been severe (e.g. leading to +respiratory or hepatic failure) and occasionally have had a fatal outcome. +The most common laboratory abnormalities (incidence ≥ 50%) were anemia, +hypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and +increased creatinine. The most common grade 3/4 laboratory abnormalities +(incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and +hypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection +(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The +rates of treatment-emergent adverse reactions resulting in permanent discontinuation +were 7% and 0% for the everolimus and placebo treatment groups, respectively. +Safety data from study [C2240] are described in detail in Section 1.4.3.3. +Overall, safety data available from completed, controlled and uncontrolled studies are +consistent with the aforementioned findings of the Phase III trial. Everolimus is +generally well tolerated at weekly and daily dose schedules. The safety profile is +characterized by manageable adverse events (AEs). These AEs are generally +reversible and non-cumulative. +Further detailed information regarding everolimus clinical development, safety and +efficacy is provided in the Investigator’s Brochure. +1.4.3.4 + +Clinical Experience with Everolimus in Metastatic Breast Cancer +Resistant to Non-Steroidal Aromatase Inhibitors + +Based on data indicating that resistance to endocrine therapy in breast cancer is +associated with activation of the mammalian target of rapamycin (mTOR) intracellular +signaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal +aromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO +daily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive +advanced breast cancer who had recurrence or progression while receiving previous +therapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat +advanced disease (or both). The primary end point was progression-free survival. +Secondary end points included survival, response rate, and safety. A preplanned +interim analysis was performed by an independent data and safety monitoring +committee after 359 progression-free survival events were observed. Baseline +characteristics were well balanced between the two study groups. The median age +was 62 years, 56% had visceral involvement, and 84% had hormone-sensitive +disease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%), +fulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse +events were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the +placebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%), +hyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At +the interim analysis, median progression-free survival was 6.9 months with +everolimus plus exemestane and 2.8 months with placebo plus exemestane, +according to assessments by local investigators (hazard ratio for progression or +death, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median +progression-free survival was 10.6 months and 4.1 months, respectively, according to +central assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study +met its pre-specified endpoint, which led to FDA approval of everolimus in +34 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +combination with exemestane for this indication in the U.S. on July 20, 2012.48 +Overall survival results were immature at the time of the interim analysis, with a total +of 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those +in the exemestane-alone group died. Patients and investigators continue to be +unaware of study assignments and will remain so until survival results are mature for +analysis.49 + +1.5 + +Rationale and Study Design + +We hypothesize more complete blockade of the ER-signaling pathway may be +achieved with selective estrogen receptor downregulator fulvestrant (given at a high +dose) than may be achieved with the steroidal AI exemestane, and that this will result +in either comparable or greater effectiveness for the fulvestrant-everolimus +combination than the exemestane-everolimus combination. This is supported by +preclinical data demonstrating that fulvestrant is particularly effective when combined +with agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone +long-term estrogen deprivation, as is the case for patients who have acquired +resistance to AI therapy.50 +We therefore propose to study the efficacy of fulvestrant in combination with +everolimus for the treatment of post-menopausal HR-positive metastatic breast +cancer in women who have progressed after treatment with an aromatase inhibitor. +The combination of a novel class of agents (mTOR inhibitors) and an established +standard treatment for metastatic HR-positive breast cancer may potentially increase +the clinical benefit by targeting multiple different biological pathways. +This is a randomized, double-blind, placebo controlled Phase II study. It is expected +that 130 patients will be accrued at 25 centers within the US. Patients will be +randomized (1:1) to receive everolimus or placebo after consideration of stratification +factors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic +disease vs. no prior chemotherapy. +Induction Phase: +Treatment during the Induction Phase includes: +Fulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1, +then 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28 +days) plus everolimus 10 mg (two- 5 mg tablets) PO daily +OR +Fulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1, +then 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28 +days) plus placebo two tablets PO daily +Patients will be evaluated for disease response every 12 weeks (every 3 treatment +cycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for +a total of up to 12 cycles. + +35 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Continuation Phase: +Patients with no evidence of progressive disease who remain on study after +completing Cycle 12 will be unblinded and proceed to the Continuation Phase. +Patients in the Continuation Phase should continue to receive fulvestrant alone (if +originally randomized to placebo) or in combination with everolimus (if originally +randomized to everolimus) at the same dose and schedule. Patients will continue to +be evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1 +week, and may continue treatment until disease progression or unacceptable toxicity. +All patients will be followed for 30 days for toxicity after the last dose of study therapy +(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) +attributed to study therapy, whichever is longer (or if >grade 1, event must be +permanent and stable). + +36 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +2 + +Objectives + +2.1 + +Primary Objective + +To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor +therapy treated with fulvestrant and everolimus compared to fulvestrant alone. + +2.2 + +Secondary Objectives + +To describe the safety profile, objective response rate, time to progression and +overall survival in this patient population. + +37 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +3 + +Selection of Patients + +3.1 + +Eligibility Criteria + +Each of the criteria in the following section must be met in order for a patient to be +considered eligible for this study. +PrECOG will not grant any exceptions or waivers to protocol eligibility criteria. +In calculating pre-treatment days of tests and measurements, the day a test or +measurement is done is considered Day 0. Therefore, if a test is done on a +Monday, the Monday four weeks later would be considered Day 28. +Note: All questions regarding eligibility should be directed to the PrECOG Study +Contact in study materials. Questions will be further discussed with the medical leads +for the trial as deemed appropriate (e.g., medical monitor, study chair). +Investigator sites may use the eligibility checklist (see Appendix A: Eligibility +Checklist) which will be provided as a separate study document, as documentation +that eligibility criteria were verified. If used, it should be reviewed, signed, and dated +prior to patient randomization by the treating physician, and all required elements of +source documentation must be found in the patient record (e.g. scans, consent, +pathology). +Inclusion Criteria: +1. Must be willing to sign a protocol-specific informed consent. +2. Patients must be 18 years of age or older. +3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B: +ECOG Performance Status Scale). +4. Patients must have histologically or cytologically confirmed adenocarcinoma +of the breast. +5. Patients must have stage IV disease or inoperable locally advanced disease. +6. Patients must have ER and/or PR-positive disease as determined by their +local pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must +be HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH +methodologies by ASCO-CAP criteria.52 +7. Patients must be Aromatase Inhibitor (AI) resistant, defined as: +• +• + +relapsed while receiving adjuvant therapy with an aromatase inhibitor +(anastrozole, letrozole, or exemestane) or, +progressive disease while receiving an aromatase inhibitor for metastatic +disease. + +Note: Patients may have received an endocrine agent (e.g., Tamoxifen) +between the time of progression on an AI and registration. + +38 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +8. Patients who have received one prior cycle (dose on day 1 and day 15) of +fulvestrant within 28 days of randomization are eligible so long as they meet +other eligibility criteria. +• + +patients previously treated with two or more prior cycles of fulvestrant are +not eligible. + +9. Patients must be female and postmenopausal, defined as: +• +• +• +• + +• + +a history of at least 12 months without spontaneous menstrual bleeding or, +prior bilateral salpingo-oophorectomy, with or without hysterectomy or, +age ≥ 55 years with a prior hysterectomy with or without oophorectomy or, +age <55 years with a prior hysterectomy without oophorectomy or +unknown status, with a documented FSH level in postmenopausal range +within 4 weeks of randomization or, +receiving a gonadotropin releasing hormone analog (GnRH) to suppress +ovarian function (e.g., goserelin 3.6 mg q 4 weeks). + +10. Patients may have received up to one prior systemic chemotherapy regimen +for metastatic disease. +11. Adequate organ function, as evidenced by ALL the following obtained within 4 +weeks of randomization*: +• +• +• +• +• +• +• + +• + +total white blood cell count (leukocytes, WBC) ≥ 3.0 x 109/L, absolute +neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L +hemoglobin ≥ 9 g/dL +serum bilirubin ≤ 1.5 x ULN +AST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases) +serum creatinine ≤ 1.5 x ULN +serum albumin ≥ 3 g/dL +fasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting +triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds +are exceeded, the patient can only be included after initiation of +appropriate lipid lowering medication. +PT with INR ≤ 1.5 (Anticoagulation is allowed if target INR ≤ 1.5 on a +stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks +at time of randomization.) + +*Please see study table in Section 7.0 for labs that may need to be repeated +within ≤ 7 days of Cycle 1 Day 1 (C1D1). +12. Patients may have measurable disease, non-measurable disease (e.g., bone +only metastases), or both per RECIST Version 1.1 Criteria. Measurable +lesions are defined as those that can be accurately measured in at least one +dimension (longest diameter to be recorded) as ≥ 20 mm by chest x-ray, as ≥ +10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All tumor +measurements must be recorded in millimeters (or decimal fractions of +centimeters). Note: Tumor lesions that are situated in a previously irradiated +area are not considered measurable. +39 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma +in situ of the cervix within the past five years must have been treated with +curative intent. Patients with a history of prior malignancy are eligible provided +they were treated with curative intent and have been free of disease for >3 +years. +Exclusion Criteria: +1. Patients who have had any major surgery or significant traumatic injury within +4 weeks of randomization, or have not recovered from the side effects of any +major surgery (defined as requiring general anesthesia) or patients that may +require major surgery during the course of the study are not eligible. +(Placement of vascular access device will not be considered major surgery.) +2. Patients may not be receiving any other investigational agents or have +received any investigational agent within 4 weeks of randomization. +3. Patients must not be receiving any concomitant anticancer treatment or have +received anticancer treatment within 4 weeks of randomization (including +chemotherapy, radiation therapy, antibody based therapy, etc.), with the +following exceptions: +• + +Bisphosphonates, Zometa or Xgeva for bone metastases + +• + +Hormonal therapy (e.g., AI, Tamoxifen) + +• + +a GnRH analog is permitted if the patient had progressive disease on a +GnRH analog plus a SERM or an AI; the GnRH analog may continue but +the SERM or AI must be discontinued. + +4. Patients must not have received prior treatment with an mTOR inhibitor +(sirolimus, temsirolimus, everolimus). +5. Patients must not be receiving chronic, systemic treatment with corticosteroids +or another immunosuppressive agent greater than or equal to 5 mg +prednisone or its equivalent daily. Topical or inhaled corticosteroids are +allowed. +6. Patients must not receive immunization with attenuated live vaccines within +one week of randomization or during the study period. Close contact with +those who have received attenuated live vaccines should be avoided during +treatment with everolimus. Examples of live vaccines include intranasal +influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella +and TY21a typhoid vaccines. +7. Patients must not have current or a prior history of brain metastases or +leptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic +involvement (>50% of the liver involved) and symptomatic lymphangitic +metastases. +8. Patients must not have a known hypersensitivity/history of allergic reactions +attributed to compounds of similar chemical or biologic composition to +everolimus (or other rapamycins such as sirolimus, temsirolimus) or +fulvestrant. +40 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +9. Since everolimus may cause bone marrow suppression, patients with +congenital or acquired immune deficiency at increased risk of infection are not +eligible. This includes patients being treated with chronic immunosuppressive +agents (including greater than or equal to 5 mg prednisone or its equivalent +daily), and patients with known HIV seropositivity. +10. Patients must not have any impairment of gastrointestinal function or +gastrointestinal disease that may significantly alter the absorption of +everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, +malabsorption syndrome or small bowel resection). +11. Patients must not have an active, bleeding diathesis. +12. Patients must not have a history of any condition or uncontrolled intercurrent +illness including, but not limited to, ongoing or active infection or psychiatric +illness/social situations that in the opinion of the local investigator might +interfere with or limit the patient’s ability to comply with the protocol or pose +additional or unacceptable risk to the patient. +13. Patients must not have any severe and/or uncontrolled medical conditions or +other conditions that could affect their participation in the study such as: +• + +Symptomatic congestive heart failure of New York Heart Association Class +III or IV (see Appendix D) + +• + +Unstable angina pectoris, myocardial infarction within 6 months of +randomization, serious uncontrolled cardiac arrhythmia or any other +clinically significant cardiac disease + +• + +History of symptomatic pulmonary disease or non-malignant pulmonary +disease (e.g. COPD) requiring treatment. Such patients would be eligible if +PFTs performed within 8 weeks of treatment noted a DLCO greater than +50%. + +• + +Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN +(Note: Optimal glycemic control should be achieved before starting trial +therapy.) + +• + +Active (acute or chronic) or uncontrolled severe infections + +• + +Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh +Class C). + +Note: A detailed assessment of Hepatitis B/C medical history and risk factors +must be done at screening for all patients. HBV DNA and HCV RNA PCR +testing are required at screening for all patients with a positive medical history +based on risk factors and/or confirmation of prior HBV/HCV infection. (see +Section 7.1.1 for additional details). + +41 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +4 + +Randomization Procedures + +4.1 + +Ethics + +This study will be conducted in accordance with the ethical principles that have their +origin in the current Declaration of Helsinki and will be consistent with applicable US +regulatory requirements and International Conference on Harmonization Good +Clinical Practice (ICH GCP). +The study will be conducted in compliance with the protocol. The protocol and any +amendments and the patient informed consent will receive Institutional Review Board +(IRB) approval prior to initiation of the study. +Freely given written informed consent must be obtained from every patient or their +legally acceptable representative prior to clinical trial participation, including informed +consent for any screening procedures conducted to establish patient eligibility for the +trial. +Study personnel involved in conducting this trial will be qualified by education, +training, and experience to perform their respective task(s). This trial will not use the +services of investigators or study personnel where sanctions have been invoked or +where there has been scientific misconduct or fraud (e.g., loss of medical licensure, +debarment). Investigators are responsible for the conduct of the study at their study +site. + +4.2 + +Regulatory Requirements + +Before a site may enter patients, protocol-specific regulatory and other documents +must be submitted to PrECOG as noted in study materials. Detailed information +regarding document submission and control is provided to each site in separate study +materials. +Once all required documents are received, reviewed and approved by PrECOG or +their representative, a Study Reference Manual (SRM) will be forwarded to the site. +Any changes to site regulatory documents must be submitted by the investigator to +the responsible party in a timely manner. Initial study drug shipment will not occur +until the regulatory packet is complete. No patients will begin protocol therapy without +formal randomization as per the process below. + +4.3 + +Patient Randomization + +Patients must meet all of the eligibility requirements listed in Section 3 prior to +randomization. Treatment must begin ≤ 7 working days from randomization. +An eligibility checklist has been appended as an example to the protocol and a usable +version is available in separate study materials provided to the site. A confirmation of +eligibility assessment by the investigator/site will be performed during the +randomization process. +Information regarding stratification factors (performance status, measurable disease +and prior chemotherapy) must be available at the time of randomization. + +42 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Once it is determined that a patient meets all eligibility requirements, the patient will +be randomized to the study by site personnel using an electronic interactive web +registration (IWR) system. Full information regarding registration and randomization +procedures and guidelines can be found in the SRM provided to your site. All +correspondence regarding patient randomization must be kept in the study records. + +43 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5 + +Treatment Plan + +5.1 + +Administration Schedule + +Note: 1 cycle = 28 days. +Patients must begin treatment within 7 working days of randomization. +Disease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds +to every 3 treatment cycles) and patients will be treated until disease progression, +unacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients +with no evidence of progressive disease who remain on study after completing 12 +cycles will be unblinded and proceed to the Continuation Phase. Patients in the +Continuation Phase should continue to receive fulvestrant alone (if originally +randomized to placebo) or in combination with everolimus (if originally randomized to +everolimus) at the same dose and schedule. Disease evaluations will continue to +occur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may +continue treatment until disease progression is documented or unacceptable toxicity. +All patients will be followed for 30 days for toxicity after the last dose of study therapy +(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) +attributed to study therapy, whichever is longer (or if >grade 1, event must be +permanent and stable). +See Sections 8.1 and 8.2 for information on study drug procurement, storage, +preparation, handling and destruction information. + +5.2 + +Dosing and Administration +5.2.1 + +Fulvestrant (Arm A and Arm B) + +Induction Phase: +Cycle 1 (28 day cycle) +Patients will receive fulvestrant 500 mg IM (two-250 mg injections each dose) +on day 1 and 15. +Note: Cycle 1 is the only time fulvestrant is given on day 15. If patient +previously received one cycle of fulvestrant (day 1 and day 15) prior to study +entry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500 +mg on day 1 only. +Cycle 2, and thereafter (28 day cycles) +Patients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of +all subsequent cycles for a maximum of 12 cycles. +Continuation Phase: +Patients with no evidence of disease progression after completing 12 cycles are +unblinded and continue fulvestrant alone (if originally randomized to placebo) or in +combination with everolimus (if originally randomized to everolimus) at the same dose +and schedule until progression of disease or unacceptable toxicity. + +44 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Fulvestrant will be obtained from commercial pharmacy stock. + +5.2.2 + +Everolimus or Placebo (Arm A and Arm B) + +• + +The study drug everolimus/placebo will be self-administered (by the patients +themselves). The local investigator will instruct the patient to take the study drug +exactly as specified in the protocol. Everolimus/placebo should be administered +orally once daily, preferably in the morning, at the same time every day with or +without food. Everolimus/placebo tablets should be swallowed whole with a glass +of water. The tablets must not be chewed or crushed. In cases where tablets +cannot be swallowed, the tablets should be disintegrated in water just prior to +being taken. Approximately 30 mL (2 tablespoons) of water should be put into a +glass. The tablets should then be added and the contents stirred gently (for a +maximum of 7 minutes) until the tablets are disintegrated. The contents should +then be drunk. If the patient vomits after taking the study drug, they should not +take another tablet that day. If the patient forgets to take the medication and +remembers by 10 PM, they may take the dose. Otherwise, skip that dose and +begin as usual the next day. + +• + +Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or +unacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy +(including guidelines for treatment beyond Cycle 12). + +• + +If vomiting occurs, no attempt should be made to replace the vomited dose. + +• + +All dosages prescribed and dispensed to the patient and all dose changes during +the study must be recorded. + +• + +PrECOG, or their designee, will be responsible for blinding, drug randomization, +and management of the electronic interactive web registration (IWR) system. Both +tablets will be blinded and identified by kit number only. The IWR system will +assign the proper kit to the patient based on the patient randomization. Conditions +for study drug will be described on the medication label. + +• + +Both everolimus and placebo will be provided by Novartis. Everolimus is +formulated as tablets for oral administration of 5 mg strength. Both placebo and +everolimus tablets are blister-packed under aluminum foil in units of 10 tablets per +blister card, which should be opened only at the time of administration as drug is +both hygroscopic and light-sensitive. + +• + +Dose modifications should be made prior to dose calculation at the beginning of +each cycle and reasons recorded in source documents and on appropriate case +report forms. + +45 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.3 + +Dose Modifications and Toxicity Management +5.3.1 + +Dose Modifications General Guidelines for Everolimus/ +Placebo + +CTCAE term (AE description) and grade: The descriptions and grading scales found +in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) +Version 4.0 will be utilized for AE reporting. All appropriate treatment areas should +have access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 +can be downloaded from the CTEP web site (http://ctep.cancer.gov). +All appropriate treatment areas should have access to a copy of the CTEP CTCAE +Version 4.0. (see Appendix E). +Dose modifications for all drugs will be made using the general guidelines below. +• + +All dose reductions are permanent. Fulvestrant will not be dose reduced. + +• + +Regardless of the reason for holding any study drug treatment, the maximum +allowable length of treatment interruption is ≤ 3 weeks. If the delivery of any study +drug due to toxicity is delayed for more than 3 weeks, that drug should be +permanently discontinued. + +• + +No more than 2 dose reductions for everolimus/placebo will be allowed. Further +need for dose reduction will result in discontinuation of that drug. + +• + +If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least +weekly until recovery to treatment levels, or as indicated in the dose modification +tables. + +• + +Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease +progression. + +• + +In unusual circumstances where fulvestrant must be discontinued prior to disease +progression due to intolerable fulvestrant-associated toxicity, the Medical Monitor +should be contacted. + +Table 5-0 +Everolimus or Placebo Dose Level Modification Guidelines +Everolimus/Placebo + +Fulvestrant + +Starting dose + +10 mg daily +(two- 5 mg tablets) + +500 mg + +Dose Level -1 + +5 mg daily + +No reduction + +Dose Level -2 + +5 mg every other day + +No reduction + +46 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Table 5-1 +Non-Hematological Criteria for Dose-Modification in Case of Suspected +Everolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus +or Placebo Treatment +Adverse Event + +Action + +Non Hematological +Reactivation of HBV or HCV flare + +Please refer to Table 5-4 and Table 5-5. + +Non-Infectious Pneumonitis + +Please refer to Table 5-6. + +AST or ALT elevation + +Maintain current dose level. + +Grade 1 (>ULN - 3.0x ULN) +Grade 2 (>3.0 - 5.0x ULN) +AST or ALT elevation +Grade 3 (>5.0 - 20.0 ULN)* + +Interrupt everolimus administration until resolution to ≤ grade 1 +(or ≤ grade 2 if baseline values were within the range of grade +2). If resolution occurs ≤ 7 days, everolimus should be re-started +at the dose level prior to interruption. +If resolution takes >7 days, or if event recurs within 28 days, +hold everolimus until recovery to ≤ grade 1 or baseline grade/ +value and reintroduce everolimus at one dose level lower, if +available. + +AST or ALT elevation +Grade 4 (>20x ULN)* + +Intolerable Grade 2 mucositis +(see Section 5.3.2.5) + +Interrupt everolimus administration until resolution to ≤ grade 1 +(or ≤ grade 2 if baseline values were within the range of grade +2). If resolution occurs ≤ 7 days, everolimus should be re-started +at one dose level lower. If resolution takes >7 days, discontinue +everolimus. +Interrupt everolimus administration until resolution to ≤ grade 1 +or baseline grade/value. +If resolution occurs within ≤ 7 days, everolimus should be restarted at the dose level prior to interruption. +If resolution takes >7 days, or if event recurs within 28 days, +hold everolimus until recovery to ≤ grade 1 or baseline grade/ +value and reintroduce everolimus at one dose level lower, if +available. +Patients will be withdrawn from the study if they fail to recover to +≤ grade 1 or baseline grade/value within 21 days. + +Grade 3 AE, except: +hyperglycemia or +hypertriglyceridemia or +hypercholesterolemia +(see Section 5.3.2.7) + +Interrupt everolimus administration until resolution to ≤ grade 1 +or baseline grade/value. +Reintroduce everolimus at one dose level lower, if available. +Patients will be withdrawn from the study if they fail to recover to +≤ grade 1 or baseline grade/value within 21 days. + +47 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 +Any other Grade 4 + +Hold everolimus until recovery to grade ≤ 1 or baseline value. +Reintroduce everolimus at one dose level lower, if available. + +Grade 3 or 4 clinical liver failure +(asterixis or encephalopathy/ +coma) + +Discontinue everolimus. + +Recurrence of intolerable Grade 2 +mucositis or Grade 3 event after +dose reduction + +Reduce dose to the next lower dose level, if available. The +lowest possible dose level of everolimus is 5 mg every other +day. Below this level, everolimus must be discontinued. + +Recurrence of Grade 4 after +dose reduction + +Discontinue everolimus. + +Any non-hematologic toxicity +requiring +interruption +of +everolimus for >21 days + +Discontinue everolimus. + +* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5). + +Table 5-2 +Hematological Criteria for Dose-Modification in Case of Suspected Everolimus +or Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo +Adverse Event + +Action + +Hematological +Grade 2 thrombocytopenia +9 + +No action. + +(platelets <75, ≥ 50 x 10 /L) +Grade 3 thrombocytopenia + +Interrupt everolimus until resolution to grade ≤1 + +(platelets <50, ≥ 25 x 10 /L) + +If resolution occurs ≤ 7 days, reintroduce everolimus at the +dose level prior to interruption. + +9 + +If resolution occurs >7 days, or event occurs within 28 days, +reintroduce everolimus at one dose level lower, if available. +Grade 4 thrombocytopenia +9 + +(platelets <25 x 10 /L) +Grade 3 neutropenia or anemia +9 + +(neutrophil <1, ≥ 0.5 x 10 /L) + +Interrupt everolimus until recovery to grade ≤ 1. Then +reintroduce everolimus at one dose level lower, if available. +Interrupt everolimus until resolution to grade ≤1 or baseline +value +If AE resolution occurs ≤ 7 days, reintroduce everolimus at +the same dose level. +If AE resolution occurs >7 days, or event occurs within 28 +days, reintroduce everolimus at one dose level lower, if +available. + +48 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 +Grade 4 neutropenia or anemia + +Interrupt everolimus until recovery to grade ≤ 1 or baseline +value. Reintroduce everolimus at one dose level lower, if +available.* + +Febrile neutropenia + +Interrupt everolimus until resolution to grade ≤ 1 (or baseline +value) and no fever. Reintroduce everolimus at one dose +level lower, if available.* + +Recurrence of Grade 3 toxicity after +dose reduction + +Reduce dose to the next lower dose level, if available. The +lowest possible dose level of everolimus is 5 mg every other +day. Below this level, everolimus must be discontinued. + +*Recurrence of Grade 4 toxicity +(including febrile neutropenia) after +dose reduction + +Discontinue everolimus. + +*Any hematologic toxicity requiring +everolimus interruption for >21 +days + +Discontinue everolimus. + +5.3.2 + +Common Adverse Events Associated with Everolimus + +The data described below reflect exposure to everolimus (n= 274) and placebo +(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell +carcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for ≥ 4 +months. The median age of patients was 61 years (range 27 to 85). The most +common adverse reactions (incidence ≥ 10%) were stomatitis, rash, fatigue, asthenia, +diarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral +edema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common +grade 3-4 adverse reactions (incidence ≥ 2%) were infections, stomatitis, fatigue, and +pneumonitis. +The median duration of blinded study treatment was 141 days (range 19 to 451) for +patients receiving everolimus and 60 days (range 21 to 295) for those receiving +placebo. The rates of treatment-emergent adverse reactions resulting in permanent +discontinuation were 7% and 0% for the everolimus and placebo treatment groups, +respectively. Most treatment-emergent adverse reactions were grade 1 or 2 in +severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39% +versus 7% of patients receiving everolimus and placebo, respectively. Deaths due to +acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were +observed on the everolimus arm. +Everolimus has immunosuppressive properties and may predispose patients to +bacterial, fungal, viral or protozoan infections, including infections with opportunistic +pathogens. Localized and systemic infections, including pneumonia, other bacterial +infections, invasive fungal infections, such as aspergillosis or candidiasis and viral +infections including reactivation of hepatitis B virus, have been described in patients +taking everolimus. Some of these infections have been severe (e.g. leading to +respiratory or hepatic failure) and occasionally have had a fatal outcome. + +49 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Physicians and patients should be aware of the increased risk of infection with +everolimus. Treat pre-existing infections prior to starting treatment with everolimus. +While taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis +of infection is made, institute appropriate treatment promptly and consider interruption +or discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is +made, discontinue everolimus and treat with appropriate antifungal therapy. +Reactivation of Hepatitis B (HBV) has been observed in patients with cancer +receiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been +seen in this setting with everolimus. Use of antivirals during anti-cancer therapy has +been shown to reduce the risk of Hepatitis B virus reactivation and associated +morbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and +risk factors must be done for all patients at screening, with testing performed prior to +the first dose of everolimus. +Hypersensitivity reactions manifested by symptoms including, but not limited to, +anaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the +airways or tongue, with or without respiratory impairment) have been observed with +everolimus. +Elevations of serum creatinine, usually mild, have been reported in clinical trials. +Monitoring of renal function, including measurement of blood urea nitrogen (BUN) or +serum creatinine, is recommended prior to the start of everolimus therapy and +periodically thereafter. +Decreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in +clinical trials. Monitoring of complete blood count is recommended prior to the start of +everolimus therapy and periodically thereafter. +The use of live vaccines and close contact with those who have received live +vaccines should be avoided during treatment with everolimus. +Hypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have +been reported as serious adverse reactions. Electrolytes should be monitored in +patients treated with everolimus. +Table 5-1 and Table 5-2 provide general recommendations for the management of +patients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy. +More detailed information regarding everolimus reported suspected toxicities and +individual cases are provided in the Investigator’s Brochure. +5.3.2.1 + +Management of Hepatitis Reactivation/Flare + +In cancer patients with hepatitis B, whether carriers or in chronic state, use of +antivirals during anticancer therapy has been shown to reduce the risk of hepatitis B +virus (HBV) reactivation and associated HBV morbidity and mortality.54 + +50 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.3.2.2 + +Monitoring and +Reactivation + +Prophylactic + +Treatment + +for + +Hepatitis + +B + +Table 5-3 provides details of monitoring and prophylactic therapy according to the +baseline results of viral load and serologic markers testing. +Table 5-3 +Action to be Taken for Positive Baseline Hepatitis B Results + +Test + +Result + +Result + +Result + +Result + +Result + +HBV-DNA + ++ + ++ or - + +- + +- + +- + +HBsAg + ++ or - + ++ + +- + +- + +- + +HBsAb + ++ or - + ++ or - + ++ + ++ or - + +- + +and no prior HBV +vaccination +HBcAb + ++ or - + +Recommendation + ++ or - + ++ or - + +or + with prior +HBV vaccination ++ + +No prophylaxis + +Prophylaxis treatment should be +started 1-2 weeks prior to first dose of +study drug + +Monitor HBV-DNA approximately +every 3-4 weeks + +No specific +action + +Monitor HBV-DNA approximately +every 4-8 weeks + +Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of +study drug. +For hepatitis B reactivation, definition and management guidelines see Table 5-4 +Guidelines for Management of Hepatitis B. + +51 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Table 5-4 +Guidelines for Management of Hepatitis B +HBV Reactivation (with or without clinical signs and symptoms)* +For patients with baseline +results: +Positive HBV-DNA + +≤ baseline HBV-DNA levels + +Positive HBsAg +-------------------------------------Reactivation is defined as: +Increase of 1 log in HBVDNA relative to baseline +HBV-DNA value OR new +appearance of measurable +HBV-DNA +For patients with baseline +results: +HBV-DNA + +AND +Interrupt study drug administration until resolution: + +OR + +Negative +HBsAg + +Treat: Start a second antiviral + +and + +If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already +receiving the lowest dose of study drug according to the protocol, the +patient should restart at the same dose after resolution. Both antiviral +therapies should continue at least 4 weeks after last dose of study +drug. +If resolution occurs >21 days, patients should discontinue study +drug but continue both antiviral therapies at least 4 weeks after last +dose of study drug. +Treat: Start first antiviral medication +AND +Interrupt study drug administration until resolution: +≤ baseline HBV-DNA levels + +AND +Positive HBsAb (with no +prior history of vaccination +against HBV), OR positive +HBcAb +------------------------------------Reactivation is defined as: +New +appearance +measurable HBV-DNA + +of + +If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already +receiving the lowest dose of study drug according to the protocol, the +patient should restart at the same dose after resolution. Antiviral +therapy should continue at least 4 weeks after last dose of study +drug. +If resolution occurs >21 days, patients should discontinue study +drug but continue antiviral therapy at least 4 weeks after last dose of +study drug. + +* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version +4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening +by the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE +Version 4.0 Metabolic Laboratory/Other: Viral Reactivation). + +5.3.2.3 + +Monitoring for Hepatitis C Flare + +The following two categories of patients should be monitored every 4-8 weeks for +HCV reactivation: +• + +Patients with detectable HCV RNA-PCR test at baseline. +52 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +• + +Patients known to have a history of HCV infection, despite a negative viral load +test at baseline (including those that were treated and are considered ‘cured’). + +For definition of hepatitis C flare and the management guidelines, see Table 5-5 +Guidelines for Management of Hepatitis C. +Table 5-5 +Guidelines for Management of Hepatitis C +HCV Flare* +For patients with baseline results: + +Discontinue study drug. + +Detectable HCV-RNA: +HCV Flare is defined as: +˃2 log10 IU/mL increase in HCV-RNA +AND +ALT elevation ˃5x ULN or 3x baseline level, +whichever is higher +Discontinue study drug. + +For patients with baseline results: +Knowledge of past hepatitis C infection +with no detectable HCV-RNA: +HCV Flare is defined as: +New appearance of detectable HCV-RNA +AND +ALT elevation ˃5x ULN or 3x baseline level, +whichever is higher + +* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0. +Metabolic Laboratory/Other: Viral Flare), unless considered life threatening by the +investigator; in which case they should be recorded as grade 4 (CTEP CTCAE +Version 4.0 Metabolic Laboratory/Other: Viral Flare). + +5.3.2.4 + +Management of Skin Toxicity + +For patients with grade 1 toxicity, no specific supportive care is usually needed or +indicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity +may be treated with the following suggested supportive measures at the discretion of +the investigator: oral minocycline, topical tetracycline, topical clindamycin, topical +silver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical +corticosteroids, or pimecrolimus. + +53 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.3.2.5 + +Management of Stomatitis/Oral Mucositis/Mouth Ulcers + +Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with +gastrointestinal morbidity associated with mouth/dental infections, irritation of +esophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing +stomatitis/mucositis must be monitored even more closely. Patients should be +instructed to report the first onset of buccal mucosa irritation/reddening to their study +physician immediately. +Suggested prophylactic treatment for prevention of stomatitis/mucositis: +a) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon +baking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not +needed); do not eat or drink anything for 10 minutes after rinsing. +b) Use 10 mL prescribed “miracle mouth wash’’ QID (swish and spit). For 16-ounce +recipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone, +and 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes +after the baking soda/salt rinse before using “miracle mouthwash’’.55 +Stomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local +supportive care. Please note that investigators in earlier trials have described the oral +toxicities associated with everolimus as mouth ulcers, rather than mucositis or +stomatitis. If your examination reveals mouth ulcers rather than a more general +inflammation of the mouth, please classify the adverse event as such. Please follow +the paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers: +1. For mild toxicity (Grade 1), use conservative measures as noted above, baking +soda/salt mouth rinse and “miracle mouth wash”. +2. For more severe toxicity (Grade 2 in which case patients have pain but are able to +maintain adequate oral alimentation, or Grade 3 in which case patients cannot +maintain adequate oral alimentation), the suggested treatments are: +In addition to baking soda/salt mouth rinse and “miracle mouth wash” +above, topical analgesic mouth treatments (e.g., local anesthetics such as +benzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol) +with or without topical corticosteroids, such as triamcinolone oral paste 0.1% +(Kenalog in Orabase®) or Periogard® oral rinse. +3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to +worsen mouth ulcers. It is preferable to avoid these agents. Alcohol–containing +rinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid +acidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather +than hot.55 +4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In +particular, systemic imidazole antifungal agents (ketoconazole, fluconazole, +itraconazole, etc.) should be avoided in all patients due to their strong inhibition of +everolimus metabolism, thereby leading to higher everolimus exposures. +Therefore, topical antifungal agents are preferred if an infection is diagnosed. +Similarly, antiviral agents such as acyclovir should be avoided unless a viral +infection is diagnosed. +Note: Stomatitis/oral mucositis should be appropriately graded using the functional +grading given on the CTEP CTCAE Version 4.0. + +54 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.3.2.6 + +Management of Diarrhea + +Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with +supportive care such as loperamide, initiated at the earliest onset (for example 4 mg +orally followed by 2 mg orally every 2 hours until resolution of diarrhea). +5.3.2.7 + +Management of Hyperlipidemia and Hyperglycemia + +Treatment of hyperlipidemia should take into account the pre-treatment status and +dietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L) +or grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated +with a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin, +pravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to +diet. +Note: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is +associated with an increased risk of a rare but serious skeletal muscle toxicity +manifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK) +levels and myoglobinuria, acute renal failure and sometimes death. The risk versus +benefit of using this therapy should be determined for individual patients based on +their risk of cardiovascular complications of hyperlipidemia. +Hyperglycemia has been reported in clinical trials. Monitoring of fasting serum +glucose is recommended prior to the start of everolimus therapy and periodically +thereafter. Optimal glycemic control should be achieved before starting trial therapy. +5.3.2.8 + +Management of Non-Infectious Pneumonitis + +Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in +patients taking everolimus. Some of these have been severe and on rare occasions, +a fatal outcome was observed. +A diagnosis of non-infectious pneumonitis should be considered in patients +presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural +effusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations. +Patients should be advised to report promptly any new or worsening respiratory +symptoms. +Patients who develop radiological changes suggestive of non-infectious pneumonitis +and have few or no symptoms may continue everolimus therapy without dose +alteration. If symptoms are moderate (Grade 2), consideration should be given to +interruption of therapy until symptoms improve. The use of corticosteroids may be +indicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade +1 or better. +For cases where symptoms of non-infectious pneumonitis are severe (Grade 3), +everolimus therapy should be discontinued and the use of corticosteroids may be +indicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated +at a reduced dose depending on the individual clinical circumstances. + +55 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +For non-infectious pneumonitis definition and management guidelines, see Table 5-6 +Management of Non-Infectious Pneumonitis. +Table 5-6 +Management of Non-Infectious Pneumonitis +Worst Grade +Pneumonitis + +Management of +Pneumonitis + +Required Investigations + +therapy + +Everolimus Dose +Adjustment + +Grade 1 + +CT scans with lung windows. + +No specific +required + +is + +No dose adjustment required. +Initiate appropriate monitoring. + +Grade 2 + +CT scan with lung windows. +Consider pulmonary function +testing includes: spirometry, +DLCO, and room air O2 +saturation at rest. Consider a +bronchoscopy +with +biopsy +and/or BAL. Monitoring at each +visit until return to ≤ grade 1. +Return to initial monitoring +frequency if no recurrence. + +Symptomatic only. +Consider +corticosteroids +and/or other supportive +therapy if symptoms are +troublesome. + +Rule out infection and consider +interruption of everolimus until +symptoms improve to Grade ≤ +1. +Re-initiate everolimus at one +dose level lower. +Discontinue +everolimus +if +failure to recover within ≤ 21 +days. + +Grade 3 + +CT scan with lung windows and +pulmonary +function +testing +includes: spirometry, DLCO, +and room air O2 saturation at +rest. Monitoring at each visit +until return to ≤ grade 1. Return +to initial monitoring frequency if +no recurrence. Bronchoscopy +with biopsy and/or BAL is +recommended. + +Consider corticosteroids if +infective origin is ruled out. +Taper +as +medically +indicated. + +Rule out infection and interrupt +everolimus until symptoms +improve to Grade ≤ 1. +Consider re-initiating everolimus at one dose level lower. +Discontinue +everolimus +if +failure to recover within ≤ 21 +days. + +Grade 4 + +CT scan with lung windows and +required pulmonary function +testing, if possible, includes: +spirometry, DLCO, and room air +O2 saturation at rest. Monitoring +at each visit until return to ≤ +grade 1. Return to initial +monitoring frequency if no +recurrence. Bronchoscopy with +biopsy +and/or +BAL +is +recommended if possible. + +Consider corticosteroids if +infective origin is ruled out. +Taper +as +medically +indicated. + +Rule +out +infection +discontinue everolimus. + +All interruptions or changes to study drug administration must be recorded. +It will be documented whether or not each patient completed the clinical study. If for +any patient either study treatment or observations were discontinued the reason will +be recorded. + +5.3.3 + +Concomitant Therapies + +Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the +local investigator. At each visit, the investigator will ask the patient about any new +medications he/she is or has taken after the start of the study drug. + +56 + +and + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Concomitant medications/significant non-drug therapies taken ≤ 28 days prior +to start and after start of study drug, including physical therapy and blood +transfusions, should be reviewed. + +5.3.4 + +Prohibited Therapies and Restrictions + +The following restrictions apply during the entire duration of the study: +• + +No other investigational therapy should be given to patients. + +• + +No anticancer agents other than the study medication should be given to patients, +with the following exceptions: +o +o + +Bisphosphonates, Zometa, or Xgeva for bone metastases +a GnRH analog is permitted if the patient had progressive disease on a GnRH +analog plus a SERM or an AI; the GnRH analog may continue but the SERM +or AI must be discontinued. + +• + +If any other anticancer agents are required for a patient then the patient must first +be withdrawn from the study. + +• + +Concurrent radiation therapy is prohibited, however palliative radiotherapy may be +considered on a case by case basis after discussion with the Study Chair. + +• + +Patients must not be receiving chronic, systemic treatment with corticosteroids or +another immunosuppressive agent greater than or equal to 5 mg prednisone or its +equivalent daily. Topical or inhaled corticosteroids are allowed. + +• + +The use of live vaccines and close contact with those who have received live +vaccines should be avoided during treatment with everolimus. Examples of live +vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, +yellow fever, varicella and TY21a typhoid vaccines. + +• + +It is highly recommended that patients with positive HBV-DNA or HBsAg are +treated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug +(see Table 5-3). + +• + +The antiviral treatment should continue throughout the entire study period and for +at least 4 weeks after the last dose of study drug. + +• + +Patients on antiviral prophylaxis treatment or positive HBV antibodies should be +tested for HBV-DNA according to study visit schedule. + +• + +Oral contraceptives in preclinical and clinical data have shown everolimus to have +CYP3A4 inhibitory activity rather than induction activity, induction of metabolism +of contraceptive hormones by everolimus is unlikely. Consequently, administration +of everolimus should not reduce the efficacy of oral contraceptives. + +• + +Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use +should be avoided. + +57 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.3.5 +5.3.5.1 + +Administration of Everolimus and CYP3A4 Inhibitors/ +Inducers + +Inhibitors of CYP3A4 and/or PgP + +Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal +wall. +Therefore, the following are recommended: +Co-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, +ritonavir) or P-glycoprotein (PgP) should be avoided. +Co-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) +or PgP inhibitors should be used with caution. If a patient requires co-administration +of moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5 +mg every other day. Additional dose reductions to every other day may be required to +manage toxicities. If the inhibitor is discontinued, the everolimus dose should be +returned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor +after a washout period of 2-3 days. +Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use +should be avoided. +Refer to Appendix C Table 15-0 for list of medications known to induce/inhibit +CYP3A4 and Table 15-1 for a list of medications known to inhibit PgP. +5.3.5.2 + +Inducers of CYP3A4 and/or PgP + +Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, +rifabutin, phenobarbital, St. John’s Wort). If a patient requires co-administration of +strong CYP3A4 inducers, an increase in the dose of everolimus up to twice the +currently used daily dose should be considered, 5 mg increments. Enzyme induction +usually occurs within 7-10 days; therefore everolimus dose should be increased by +one increment 7 days after the start of the inducer therapy. If no safety concerns are +seen within the next 7 days, the dose can be increased again one additional +increment up to a maximum of twice the daily dose used prior to initiation of the +strong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient +requiring co-administration of strong CYP3A4 inducers will be done at the discretion +of the treating investigator. +This dose adjustment of everolimus is intended to achieve similar AUC to the range +observed without inducers. However, there are no clinical data with this dose +adjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is +discontinued the everolimus dose should be returned to the dose used prior to +initiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list +of medications known to induce CYP3A4 and Table 15-1 for a list of medications +known to induce PgP. +Oral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no +interaction with everolimus is expected. However, drug-drug interaction studies +between macrolide antibiotics and warfarin have produced mixed outcomes and the +disparity in these findings has led to the conclusion that multiple factors may alter the + +58 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +clearance of warfarin. The co-administration of everolimus and oral anticoagulants is +possible but should be subject to verification of coagulation (INR) once steady state is +reached (after one week’s treatment). +A comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors, +inducers, and substrates can be found at: +http://medicine.iupui.edu/clinpharm/ddis/table.aspx. This +revised and should be checked frequently for updates. + +5.4 + +website + +is + +continually + +Supportive Care + +All supportive measures consistent with optimal patient care will be given throughout +the study. +The clinical tolerance of the patient, the overall tumor response, and the medical +judgment of the investigator will determine if it is in the patient’s best interest to +continue or discontinue treatment. If treatment is discontinued due to any toxicity, the +patient must be followed to monitor duration of toxicity, response and time to +progression or survival and initiation of any new systemic therapy. + +5.5 + +Duration of Therapy + +CR, PR, or SD patients will continue therapy per their induction arm randomized +assignments until evidence of progressive disease, unacceptable toxicity occurs, or +for a total of 12 cycles (Induction Phase). Patients with no evidence of progressive +disease who remain on study after completing 12 cycles will be unblinded and +proceed to the Continuation Phase. Patients in the Continuation Phase should +continue to receive fulvestrant alone (if originally randomized to placebo) or in +combination with everolimus (if originally randomized to everolimus) at the same dose +and schedule until disease progression or unacceptable toxicity. +Protocol therapy will be discontinued for progressive disease at any time. Patients are +free to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe +administration of study drugs. +Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease +progression. In unusual circumstances where fulvestrant must be discontinued prior +to disease progression due to intolerable fulvestrant-associated toxicity, the medical +monitor should be contacted. All patients who have discontinued protocol therapy will +be followed for survival and for progression if protocol therapy was discontinued +because of toxicity or for other reasons. All surviving patients who have discontinued +induction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be +followed for 30 days for study drug related (fulvestrant and/or everolimus/placebo) +toxicities to ≤ grade 1 (or if >grade 1, event must be permanent and stable). + +59 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +5.6 + +Withdrawal of Patients from Study + +Patients MUST be discontinued from study therapy AND be withdrawn from the study +for the following reasons: +• + +Withdrawal of the patient’s consent (patient’s decision to withdraw for any reason) + +• + +Termination of the study by PrECOG + +• + +Any clinical adverse event, laboratory abnormality or intercurrent illness which, in +the opinion of the investigator, indicates that continued participation in the study is +not in the best interest of the subject + +• + +Inability to comply with protocol + +• + +Discretion of the investigator + +• + +Disease progression (patient will continued to be followed for survival) + +All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5. +If a subject is withdrawn before completing the study, the reason for withdrawal must +be entered on the appropriate case report form. + +60 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +6 + +Measurement of Effect + +6.1 + +Antitumor Effect- Solid Tumors + +For the purposes of this study, patients should be re-evaluated for response every 12 +weeks, +/- 1 week. All baseline evaluations should be performed as closely as +possible to the beginning of treatment and never more than four weeks before +randomization. +Response and progression will be evaluated in this study using the new international +criteria proposed by the revised Response Evaluation Criteria in Solid Tumors +(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional +measurement) of the tumor lesions and the shortest diameter in the case of malignant +lymph nodes are used in the RECIST criteria. + +6.1.1 + +Definitions + +Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their +first treatment with fulvestrant and everolimus/placebo. All patients will be followed for +30 days for toxicity after the last dose of study therapy (fulvestrant and/or +everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) attributed to study +therapy, whichever is longer (or if >grade 1, event must be permanent and stable). +Evaluable for objective response: Only those patients who have measurable disease +present at baseline, have received at least one cycle of therapy, and have had their +disease re-evaluated will be considered evaluable for response. These patients will +have their response classified according to the definitions stated below. (Note: +Patients who exhibit objective disease progression prior to the end of Cycle 1 will also +be considered evaluable.) +Evaluable non-target disease response: Patients who have lesions present at +baseline that are evaluable but do not meet the definitions of measurable disease, +have received at least one cycle of therapy, and have had their disease re-evaluated +will be considered evaluable for non-target disease. The response assessment is +based on the presence, absence, or unequivocal progression of the lesions. + +6.1.2 + +Disease Parameters + +Measurable lesions: are defined as those that can be accurately measured in at least +one dimension (longest diameter in the plane of measurement) is to be recorded with +a minimum size of: +• + +≥ 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung) + +• + +≥ 10 mm with CT scan (irrespective of scanner type) and MRI (no less than +double the slice thickness and a minimum of 10 mm) + +• + +≥ 10 mm with calipers by clinical exam when superficial + +All tumor measurements must be recorded in millimeters (or decimal fractions of +centimeters). + +61 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Note: Tumor lesions that are situated in a previously irradiated area, or in an area +subjected to other loco-regional therapy, are usually not considered measurable +unless there has been demonstrated progression in the lesion. +Malignant lymph nodes: to be considered pathologically enlarged and measurable, a +lymph node must be ≥ 15 mm in short axis (perpendicular to longest diameter) when +assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 +mm). At baseline and in follow-up, only the short axis will be measured and followed. +Non-measurable lesions: all other lesions (or sites of disease), including small lesions +(longest diameter <10 mm or pathological lymph nodes with ≥ 10 to <15 mm short +axis), are considered non-measurable disease. Leptomeningeal disease, ascites, +pleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast +disease, and abdominal masses/organomegaly (not followed by CT or MRI), are +considered as non-measurable. +Note: Cystic lesions that meet the criteria for radiographically defined simple cysts +should not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts. +‘Cystic lesions’ thought to represent cystic metastases can be considered as +measurable lesions, if they meet the definition of measurability described above. +However, if non-cystic lesions are present in the same patient, these are preferred for +selection as target lesions. +Lytic bone lesions, with an identifiable soft tissue component, evaluated by CT or +MRI, can be considered as measurable lesions if the soft tissue component otherwise +meets the definition of measurability noted above. Blastic bone lesions are nonmeasurable. + +6.1.3 + +Methods for Evaluation of Measurable Disease + +All measurements should be taken and recorded in metric notation using a ruler or +calipers. All baseline evaluations should be performed as closely as possible to the +beginning of treatment and never more than 4 weeks before randomization. +The same method of assessment and the same technique should be used to +characterize each identified and reported lesion at baseline and during follow-up. +Imaging-based evaluation is preferred to evaluation by clinical examination unless the +lesion(s) being followed cannot be imaged but are assessable by clinical exam. +Clinical lesions: Clinical lesions will only be considered measurable when they are +superficial (e.g., skin nodules and palpable lymph nodes) and ≥ 10 mm diameter as +assessed using calipers (e.g., skin nodules). In the case of skin lesions, +documentation by color photography, including a ruler to estimate the size of the +lesion, is recommended. +Chest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they +are clearly defined and surrounded by aerated lung. However, CT is preferable. + +62 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Conventional CT and MRI: This guideline has defined measurability of lesions on CT +scan based on the assumption that CT slice thickness is 5 mm or less. If CT scans +have slice thickness greater than 5 mm, the minimum size for a measurable lesion +should be twice the slice thickness. MRI is also acceptable in certain situations (e.g. +for body scans). +Use of MRI remains a complex issue. MRI has excellent contrast, spatial, and +temporal resolution; however, there are many image acquisition variables involved in +MRI, which greatly impact image quality, lesion conspicuity, and measurement. +Furthermore, the availability of MRI is variable globally. As with CT, if an MRI is +performed, the technical specifications of the scanning sequences used should be +optimized for the evaluation of the type and site of disease. Furthermore, as with CT, +the modality used at follow-up should be the same as was used at baseline and the +lesions should be measured/assessed on the same pulse sequence. It is beyond the +scope of the RECIST guidelines to prescribe specific MRI pulse sequence +parameters for all scanners, body parts, and diseases. Ideally, the same type of +scanner should be used and the image acquisition protocol should be followed as +closely as possible to prior scans. Body scans should be performed with breath-hold +scanning techniques, if possible. +PET-CT: At present, the low dose or attenuation correction CT portion of a combined +PET-CT is not always of optimal diagnostic CT quality for use with RECIST +measurements. However, if the site can document that the CT performed as part of a +PET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast), +then the CT portion of the PET-CT can be used for RECIST measurements and can +be used interchangeably with conventional CT in accurately measuring cancer +lesions over time. Note, however, that the PET portion of the CT introduces additional +data which may bias an investigator if it is not routinely or serially performed. +Ultrasound: Ultrasound is not useful in assessment of lesion size and should not be +used as a method of measurement. Ultrasound examinations cannot be reproduced +in their entirety for independent review at a later date and, because they are operator +dependent, it cannot be guaranteed that the same technique and measurements will +be taken from one assessment to the next. If new lesions are identified by ultrasound +in the course of the study, confirmation by CT or MRI is advised. If there is concern +about radiation exposure at CT, MRI may be used instead of CT in selected +instances. +Endoscopy, Laparoscopy: The utilization of these techniques for objective tumor +evaluation is not advised. However, such techniques may be useful to confirm +complete pathological response when biopsies are obtained or to determine relapse +in trials where recurrence following complete response (CR) or surgical resection is +an endpoint. +Tumor markers: Tumor markers alone cannot be used to assess response. If markers +are initially above the upper normal limit, they must normalize for a patient to be +considered in complete clinical response. Specific guidelines for both CA-125 +response (in recurrent ovarian cancer) and PSA response (in recurrent prostate +cancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has +developed CA-125 progression criteria which are to be integrated with objective +tumor assessment for use in first-line trials in ovarian cancer.60 +63 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Cytology, Histology: These techniques can be used to differentiate between partial +responses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in +tumor types, such as germ cell tumors, where known residual benign tumors can +remain). +The cytological confirmation of the neoplastic origin of any effusion that appears or +worsens during treatment when the measurable tumor has met criteria for response +or stable disease is mandatory to differentiate between response or stable disease +(an effusion may be a side effect of the treatment) and progressive disease. +FDG-PET: While FDG-PET response assessments need additional study, it is +sometimes reasonable to incorporate the use of FDG-PET scanning to complement +CT scanning in assessment of progression (particularly possible 'new' disease). New +lesions on the basis of FDG-PET imaging can be identified according to the following +algorithm: +• +• + +• + +Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of +PD based on a new lesion. +No FDG-PET at baseline and a positive FDG-PET at follow-up: +o If the positive FDG-PET at follow-up corresponds to a new site of disease +confirmed by CT, this is PD. +o If the positive FDG-PET at follow-up is not confirmed as a new site of disease +on CT, additional follow-up CT scans are needed to determine if there is truly +progression occurring at that site (if so, the date of PD will be the date of the +initial abnormal FDG-PET scan). +o If the positive FDG-PET at follow-up corresponds to a pre-existing site of +disease on CT that is not progressing on the basis of the anatomic images, +this is not PD. +FDG-PET may be used to upgrade a response to a CR in a manner similar to a +biopsy in cases where a residual radiographic abnormality is thought to represent +fibrosis or scarring. The use of FDG-PET in this circumstance should be +prospectively described in the protocol and supported by disease-specific medical +literature for the indication. However, it must be acknowledged that both +approaches may lead to false positive CR due to limitations of FDG-PET and +biopsy resolution/sensitivity. + +Note: A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake +greater than twice that of the surrounding tissue on the attenuation corrected image. + +6.1.4 +6.1.4.1 + +Response Criteria + +Evaluation of Target Lesions + +All measurable lesions up to a maximum of 2 lesions per organ and five lesions in +total, representative of all involved organs, should be identified as target lesions and +recorded and measured at baseline. Target lesions should be selected on the basis +of their size (those with the longest diameters), be representative of all involved +organs, but in addition should be those that lend themselves to reproducible repeated +measurements. It may be the case that, on occasion, the largest lesion does not lend +itself to reproducible measurement in which circumstance the next largest lesion +which can be measured reproducibly should be selected. + +64 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) +for all target lesions will be calculated and reported as the baseline sum diameters. If +lymph nodes are to be included in the sum, then only the short axis is added into the +sum. The baseline sum of the diameters will be used as reference to further +characterize any objective tumor regression in the measurable dimension of the +disease. +Complete Response (CR): Disappearance of all target lesions. Any pathological +lymph nodes (whether target or non-target) must have reduction in short axis to <10 +mm. +Partial Response (PR): At least a 30% decrease in the sum of the diameters of target +lesions, taking as reference the baseline sum diameters. +Progressive Disease (PD): At least a 20% increase in the sum of the diameters of +target lesions, taking as reference the smallest sum on study (this includes the +baseline sum if that is the smallest on study). In addition to the relative increase of +20%, the sum must also demonstrate an absolute increase of at least 5 mm over the +nadir. (Note: the appearance of one or more new lesions is also considered +progression). +Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient +increase to qualify for PD, taking as reference the smallest sum diameters while on +study. (Note: a change of 20% or more that does not increase the sum of the +diameters by 5 mm or more is coded as stable disease). +6.1.4.2 + +Evaluation of Non-Target Lesions + +All other lesions or sites of disease including any measurable lesions over and above +the 5 target lesions should be identified as non-target lesions and should also be +recorded at baseline. Measurements of these lesions are not required, but the +presence or absence of unequivocal progression of each should be noted throughout +follow-up. +Complete Response (CR): Disappearance of all non-target lesions and normalization +of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm +short axis). +Note: If tumor markers are initially above the upper normal limit, they must normalize +for a patient to be considered in complete clinical response. +Non-CR/Non-PD: Persistence of one or more non-target +maintenance of tumor marker level above the normal limits. + +lesion(s) + +and/or + +Progressive Disease (PD): Appearance of one or more new lesions and/or +unequivocal progression of existing non-target lesions. Unequivocal progression +should not normally trump target lesion status. It must be representative of overall +disease status change, not a single lesion increase. +When the patient also has measurable disease, there must be an overall level of +substantial worsening in non-target disease such that, even in the presence of SD or +PR in target disease, the overall tumor burden has increased sufficiently to merit +discontinuation of therapy. A modest “increase” in the size of one or more non-target +lesions is usually not sufficient to qualify for unequivocal progression status. The +65 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +designation of overall progression solely on the basis of change in non-target disease +in the face of SD or PR of target disease will therefore be extremely rare. +When the patient only has non-measurable disease, the increase in overall disease +burden should be comparable in magnitude to the increase that would be required to +declare PD for measurable disease: i.e., an increase in tumor burden from “trace” to +“large”, an increase in nodal disease from “localized” to “widespread”, or an increase +sufficient to require a change in therapy. +Although a clear progression of “non-target” lesions only is exceptional, the opinion of +the treating physician should prevail in such circumstances, and the progression +status should be confirmed at a later time by the review panel (or Principal +Investigator). +6.1.4.3 + +Evaluation of New Lesions + +The appearance of new lesions constitutes Progressive Disease (PD). +6.1.4.4 + +Evaluation of Patient’s Best Overall Response + +The best overall response is the best response recorded from the start of the +treatment until disease progression/recurrence (taking as reference for progressive +disease the smallest measurements recorded since the treatment started). The +patient's best response assignment will depend on the achievement of both +measurement and confirmation criteria. + +66 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Table 6-0 +Patients with Measurable Disease (e.g., Target Disease) +Target +Lesions + +Non-Target +Lesions + +New +Lesions + +Overall +Response + +Best Overall Response when +Confirmation is Required* + +CR + +CR + +No + +CR + +Confirmation not required + +CR + +Non-CR/NonPD + +No + +PR + +CR + +Not Evaluated + +No + +PR + +PR + +Non-CR/NonPD/Not +Evaluated + +No + +PR + +SD + +Non-CR/NonPD/Not +Evaluated + +No + +SD + +PD + +Any + +Yes or No + +PD + +Any + +PD** + +Yes or No + +PD + +Any + +Any + +Yes + +PD + +Confirmation not required + +Confirmation not required + +No prior SD, PR or CR + +*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. +**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as +disease progression. +Note: + +Patients with a global deterioration of health status requiring discontinuation of treatment +without objective evidence of disease progression at that time should be reported as +“symptomatic deterioration”. Every effort should be made to document the objective +progression even after discontinuation of treatment. + +Table 6-1 +Patients with Non-Measurable Disease (e.g., Non-Target Disease) +Non-Target Lesions + +New Lesions + +Overall Response + +CR + +No + +CR + +Non-CR/Non-PD + +No + +Non-CR/Non-PD* + +Not all evaluated + +No + +Not Evaluated + +Unequivocal PD + +Yes or No + +PD + +Any + +Yes + +PD + +*‘Non-CR/Non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly +used as an endpoint for assessment of efficacy in some trials so to assign this category when no +lesions can be measured is not advised. + +67 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +6.1.5 + +Duration of Response + +Duration of overall response: The duration of overall response is measured from the +time measurement criteria are met for CR or PR (whichever is first recorded) until the +first date that recurrent or progressive disease is objectively documented (taking as +reference for PD the smallest measurements recorded since the treatment started). +The duration of overall CR is measured from the time measurement criteria are first +met for CR until the first date that progressive disease is objectively documented. +Duration of stable disease: Stable disease is measured from the start of the treatment +until the criteria for progression are met, taking as reference the smallest +measurements recorded since the treatment started, including the baseline +measurements. + +6.1.6 + +Progression-Free Survival + +PFS is defined as the duration of time from time of randomization to time of +progression or death, whichever occurs first. A subject who has neither progressed +nor died will be censored on the date of last tumor assessment. + +68 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +7 + +Study Parameters + +TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION +Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) +Procedure + +Pre-Study + +Cycle 1 + +Cycle 1 + +Day 1* + +Day 15 + +Day 1 Each +Subsequent +Cycle* + +Every 12 +weeks + +End of +Induction +Phase + +Continuation + + + +progression or + +End of +Treatment + +unacceptable + +Phase +(until + +toxicity) + +Section 5.6^ + +X + +Informed Consent + +X + +Medical History & Assessment of Baseline +Signs and Symptoms + +X + +Physical Exam + +X + +a + +X + +a + +Vital Signs (Blood Pressure, Heart Rate, +Temperature) and Weight +ECOG Performance Status + +Follow-Up Off +o +Therapy +(every 3 +months for total +of 3 yrs from +date of +randomization) + +a + +Eligibility Assessment + +Concomitant Meds (see Appendix C) + +£ + +a + +X + +a + +X +(includes Ht) +a + +X + +b + +X + +X + +c + +X + +b + +X + +X + +c + +X + +X + +X + +b + +X + +X + +c + +X + +b + +X + +X + +c + +X + +X + +c + +X + +j + +X + +X + +i + +X + +X + +b + +Adverse Events Assessments + +X + +X + +a,i + +i + +Imaging Scans + +X + +X + +PT with INR + +X + +Urinalysis + +X + +CBC with differentials, Platelets + +X + +a + +X + +b + +X + +d + +X + +Serum Creatinine, Electrolytes (K, Na, Cl, +CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), +Alkaline Phosphatase, Total Bilirubin, +Magnesium, Uric Acid. + +X + +a + +X + +b + +X + +X + +Fasting Glucose + +X + +a + +X + +b + +X + +e + +X + +e + +Fasting serum Lipid Profile (triglycerides, +total cholesterol, HDL and LDL) + +X + +a + +X + +b + +X + +e + +X + +e + +X + +j + +i + +a +a + +69 + +c,d + +X + +d + +X + +k + +c + +X + +X + +X + +e + +X + +e + +X + +k + +k +k + +j + +X + +i,m,o + +X + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 +Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles) +Procedure + +Pre-Study + +Cycle 1 + +Cycle 1 + +Day 1* + +Day 15 + +Day 1 Each +Subsequent +Cycle* + +Every 12 +weeks + +End of +Induction +Phase + +Continuation +Phase +(until + + + +progression or + +End of +Treatment + +unacceptable +toxicity) + +Section 5.6^ + +HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR + +(every 3 +months for total +of 3 yrs from +date of +randomization) + +a,f +f,g + +X + +f,h + +X + +X + +HCV RNA-PCR + +X + +PFTs with DLCO as medically indicated + +Follow-Up Off +o +Therapy + +X + +HBV DNA +Study Drug Compliance (Pill Diary) + +£ + +X + +f,g + +X + +f,h + +X + +X + +k +k + +X + +l + +X + +n + +a: ≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs). +b: ≤ 7 days prior to the start of C1D1. +c: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends, +bad weather or other unforeseen circumstances will be permitted. +d: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of +hematologic recovery. +e: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of +treatment. +f: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a +positive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or +HBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment +should continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus. +g: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior +to D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions. +h: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNAPCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be +discontinued if HCV flare is confirmed according to the guidance in Table 5-5. +i: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week +(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be +repeated once disease progression is documented. +j: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or +everolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last +dose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo. +70 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 +k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone. +Patients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per +labeling guidelines. +l: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase. +m: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed +during the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented +progression. +n: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study). +o: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented. +* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15 +of the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo. +^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant. +£ Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination +with everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to +holidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity. + +71 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +7.1 + +Procedures by Visit + +Written informed consent must be obtained prior to any study required procedures that +would not have been performed as part of normal patient care at the site. + +7.1.1 + +Pre-Study + +Prior to randomization, patients will complete the informed consent process and have all +required protocol assessments completed in order to assess eligibility requirements. All +procedures and an assessment of eligibility should be documented in the patient record. +Within ≤ 4 weeks of randomization to protocol therapy: +• + +Medical history + +• + +Assessment of baseline signs and symptoms + +• + +Physical examination + +• + +Concomitant medication assessment (see Appendix C for list of excluded or +medications requiring monitoring on study) + +• + +Vital signs, including blood pressure, heart rate and temperature, height and weight + +• + +Assessment of ECOG performance status + +• + +Imaging scans for complete disease assessment. Care should be taken to continue +to use the same evaluation method during the study as used for initial evaluation. +See Section 6 for additional details. + +• + +PT with INR + +• + +Urinalysis + +• + +CBC with differential and platelets + +• + +Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, +Magnesium and Uric Acid + +• + +Fasting Glucose + +• + +Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) + +A detailed assessment of hepatitis B/C medical history and risk factors must be done for +all patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a +course of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in +Section 5.3.2.2 and 5.3.2.3). +Testing for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb, +HBcAb and HCV RNA-PCR are required at screening for all patients in the following risk +categories: +o All patients who have lived in Asia, Africa, Central and South America, Eastern +Europe, Spain, Portugal, and Greece. +[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm] + +72 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +o Patients with any of the following risk factors: +• known or suspected past hepatitis B infection +• blood transfusion(s) prior to 1990 +• current or prior IV drug users +• current or prior dialysis +• household contact with hepatitis B infected patient(s) +• current or prior high-risk sexual activity +• body piercing or tattoos +• mother known to have hepatitis B +• history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right +upper quadrant pain. +o Additional patients at the discretion of the investigator + +Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for +all patients in the following risk categories: +o +o +o +o +o +o +o +o + +known or suspected past hepatitis C infection (including patients with past +interferon ‘curative’ treatment) +blood transfusions prior to 1990 +current or prior IV drug users +current or prior dialysis +household contact of hepatitis C infected patient(s) +current or prior high-risk sexual activity +body piercing or tattoos +At the discretion of the investigator, additional patients may also be tested for +hepatitis C. + +Final determination of eligibility and randomization to therapy should be done only after +all assessments are completed. + +7.1.2 + +Induction Phase (fulvestrant + everolimus/placebo) + +Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first +fulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant +doses is given on day 15 of the first cycle only). Note: If patient previously received one +cycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion +Criteria #8, patient should receive fulvestrant 500 mg on day 1 only. +Patients will be assessed continually for toxicity and study continuation. Protocol therapy +doses should be calculated and modified as per Section 5. Assessment of disease for +response should be performed as per Section 6. +One cycle in the Induction Phase is equal to 28 days. Patients are treated for a +maximum of 12 cycles in the Induction Phase. +7.1.2.1 + +Within 7 Days of Cycle 1 Day 1 + +Note: The following assessments do not have to be repeated if the pre-study +assessments were performed within ≤ 7 days of Cycle 1 Day 1. + +73 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +• + +Physical examination + +• + +Concomitant medication assessment (see Appendix C for list of excluded or +medications requiring monitoring on study) + +• + +Vital signs, including blood pressure, heart rate, temperature and weight + +• + +Assessment of ECOG performance status + +• + +Adverse event assessment and dose modifications as necessary (AEs should be +monitored continuously). AE assessment should begin after the first dose of study +medication has been administered. + +• + +CBC with differential and platelets + +• + +Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, +Magnesium and Uric Acid + +• + +Fasting Glucose + +• + +Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) + +• + +Patients on antiviral prophylaxis treatment or positive HBV antibodies should be +tested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 +days) to monitor for re-activation. If re-activation is confirmed, everolimus must be +interrupted or discontinued according to the guidance in Table 5-4. Patients with +positive HCV RNA-PCR results at screening and/or a history of past infection (even if +treated and considered ‘cured’) should have HCV RNA-PCR testing performed on +Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for +flare. Everolimus must be discontinued if HCV reactivation is confirmed according to +the guidance in Table 5-5. + +7.1.2.2 + +Cycle 1 Day 15 + +• + +Physical examination + +• + +Concomitant medication assessment (see Appendix C for list of excluded or +medications requiring monitoring on study) + +• + +Vital signs, including blood pressure, heart rate, temperature, and weight + +• + +Assessment of ECOG performance status + +• + +Adverse event assessment and dose modifications as necessary (AEs should be +monitored continuously). (see Section 5.3 for dose modification guidelines) + +• + +CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity, +CBC with differentia and platelet count will be obtained every 1-3 days until there is +evidence of hematologic recovery. + +• + +Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, +Magnesium and Uric Acid + +• + +Study Drug Compliance (Pill Diary) for everolimus/placebo + +74 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +7.1.2.3 + +Cycle 2 (and each subsequent cycle) Day 1 + +• + +Physical examination + +• + +Concomitant medication assessment (see Appendix C for list of excluded or +medications requiring monitoring on study) + +• + +Vital signs, including blood pressure, heart rate, temperature and weight + +• + +Assessment of ECOG performance status + +• + +Adverse event assessment and dose modifications as necessary (AEs should be +monitored continuously, see Section 5.3 for dose modification guidelines). + +• + +CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity, +CBC with differential and platelet count will be obtained every 1-3 days until there is +evidence of hematologic recovery. + +• + +Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, +Magnesium and Uric Acid + +• + +Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more +frequently as clinically indicated) + +• + +Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2 +Day 1, then every 12 weeks during treatment, and more frequently as clinically +indicated) + +• + +Patients on antiviral prophylaxis treatment or positive HBV antibodies should be +tested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 +days) to monitor for re-activation. If re-activation is confirmed, everolimus must be +interrupted or discontinued according to the guidance in Table 5-4. Patients with +positive HCV RNA-PCR results at screening and/or a history of past infection (even if +treated and considered ‘cured’) should have HCV RNA-PCR testing performed on +Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for +flare. Everolimus must be discontinued if HCV reactivation is confirmed according to +the guidance in Table 5-5. + +• + +Study Drug Compliance (Pill Diary) for everolimus/placebo + +7.1.2.4 + +Every 12 Weeks + +• + +Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction +Phase. Scans should be repeated at the assigned intervals regardless of cycle or +treatment delays. + +• + +Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL +and LDL) to be done every 12 weeks during Induction Phase (and more frequently +as clinically indicated) + +75 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +7.1.3 + +End of Induction Phase End of Treatment + +All patients will have the following assessments completed whether they are moving into +the Continuation Phase or no longer will be receiving treatment and are moving into +Follow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments +should be completed within 30 days of last dose of fulvestrant and before moving from +the Induction Phase into the Continuation Phase or before moving directly into the +Follow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle +12 if the assessments below are completed in order to maintain the 28 day fulvestrant +dosing schedule). +• + +Physical examination + +• + +Concomitant medication assessment (see Appendix C for list of excluded or +medications requiring monitoring on study) + +• + +Vital signs, including blood pressure, heart rate, temperature and weight + +• + +Assessment of ECOG performance status + +• + +Adverse event assessment. All patients will be followed for toxicity assessment for +30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo) +or until resolution to ≤ grade 1 attributed to study therapy (or if >grade 1, event must +be permanent and stable). Serious adverse events >30 days after last dose of +fulvestrant and/or everolimus/placebo are not reported unless the event may be +related to everolimus/placebo. + +• + +Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation +schedule. + +• + +CBC with differential and platelets + +• + +Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, +Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, +Magnesium and Uric Acid + +• + +Fasting Glucose + +• + +Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) + +• + +Study Drug Compliance (Pill Diary) for everolimus/placebo + +Patients in the Continuation Phase should continue to receive fulvestrant alone (if +originally randomized to placebo) or in combination with everolimus (if originally +randomized to everolimus) at the same dose and schedule until disease progression or +unacceptable toxicity. +Patients that are moving from the Induction Phase into Follow-Up Off Therapy should +not receive further investigational therapies for at least 30 days after the last dose of +study drug, if possible, in order to eliminate overlapping toxicity. + +76 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +7.1.4 + +Continuation Phase (fulvestrant +/- everolimus) + +Patients with no evidence of disease progression after 12 cycles of treatment (Induction +Phase) will be unblinded and proceed to the Continuation Phase. Patients in the +Continuation Phase should continue to receive fulvestrant alone (if originally randomized +to placebo) or in combination with everolimus (if originally randomized to everolimus) at +the same dose and schedule until disease progression is documented or unacceptable +toxicity. Once progression is documented, patients will move into Follow-Up Off Therapy. +One cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation +Phase should start 28 days (D29) after the last dose of fulvestrant was given during +Cycle 12 in the Induction Phase. +All adverse events that are related to fulvestrant and/or everolimus will be followed for 30 +days after the last dose of study therapy (fulvestrant and/or everolimus) until ≤ grade 1 +or if the grade is >1, the event must be permanent and stable. +• + +CBC and chemistry may be used to monitor any ongoing toxicities, but are not +required for patients that receive fulvestrant alone. + +• + +Patients who continue fulvestrant in combination with everolimus should periodically +have CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV +RNA-PCR per labeling guidelines. + +• + +Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the +Continuation Phase. + +After the Continuation Phase, serious adverse events >30 days after last dose of +fulvestrant and/or everolimus are not reported unless the event may be related to +everolimus. +7.1.4.1 +• + +Every 12 Weeks + +Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the +Continuation Phase until disease progression is documented. + +7.1.5 + +Follow-Up Off-Therapy + +All patients, including those who discontinue protocol therapy, will be followed for 3 +years from the time of randomization. Patients that did not progress during the Induction +or Continuation Phase will continue to have imaging scans completed every 3 months +until documented progression. Patients will then be followed for survival. Initiation of any +new systemic therapy will also be documented. Patients that have adverse events +related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last +dose of study therapy (fulvestrant and/or everolimus/placebo) until ≤ grade 1 or if the +grade is >1, the event must be permanent and stable. Serious adverse events >30 days +after last dose of fulvestrant and/or everolimus/placebo are not reported unless the event +may be related to everolimus/placebo. + +77 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +8 + +Drug Formulation and Procurement + +8.1 + +Everolimus +8.1.1 + +Packaging and Labeling + +Full instructions for investigator sites and investigational pharmacies will be available in +separate protocol-specific documents. The supply of everolimus or placebo will be +shipped directly to the local investigator. Drug ordering procedures will be provided in +supplemental study materials. +8.1.1.1 + +How Supplied + +Everolimus and an identically appearing placebo will be provided by Novartis. +Everolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are +blister-packed under aluminum foil in units of 10 tablets per blister card, which should be +opened only at the time of administration as drug is both hygroscopic and light-sensitive. +Each tablet contains as inactive ingredients: butylhyroxytoluene/butylated +hydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose, +crospovidone and lactose anhydrous. +Medication labels will comply with US legal requirements and be printed in English. They +will supply no information about the patient. The storage conditions for study drug will be +described on the medication label. + +8.1.2 + +Storage Requirements/Stability + +Everolimus should be stored at room temperature between 20°C to 25°C (68°F to 77°F). +All investigational products must be kept in a secure place under appropriate storage +conditions. A description of the appropriate storage and shipment conditions is specified +on the investigational product label and investigator brochure. The stored study drug +supplies must be accessible to authorized staff only. The storage area must also have +adequate control of temperature in order to maintain stability and potency of study drug +supplies. The tablets should be stored in the original pack until use. For further +information, investigators should refer to the current Investigators Brochure (IB). + +8.1.3 +8.1.3.1 + +Handling, Dispensing and Administration + +Handling + +No special precautions are necessary when handling intact tablets. Avoid contact with +skin and eyes. Wash hands after use. The risk to health in normal handling of tablets is +very low. Exposure to dust from crushed tablets may cause adverse health effects. +8.1.3.2 + +Dispensing + +Drug should be dispensed in original packaging. If other packaging is required by +institutional policy, this procedure will need to be approved by PrECOG, or their +designee, prior to proceeding. The PrECOG Site Contact should be contacted for further + +78 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +instruction. Investigational product records should be kept as per Section 8.1.5 and +institutional policies. +8.1.3.3 + +Administration + +Patients should be instructed to take their assigned, once-a-day oral dose of +everolimus/placebo at the same time each morning. +• + +Everolimus/placebo dose may be taken with or without food. + +• + +Patients should be instructed to swallow the capsules whole and not chew them. + +• + +Vomited doses should not be replaced. + +• + +If the patient forgets to take the medication and remembers by 10 PM, they may take +the dose. Otherwise, skip that dose and begin as usual the next day. + +In cases where tablets cannot be swallowed, the tablets should be disintegrated in water +just prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put +into a glass. The tablets should then be added and the contents stirred gently (for a +maximum of 7 minutes) until the tablets are disintegrated. The contents should then be +drunk. +Patients should be given instructions on correct dosing based on study requirements +and toxicity management (dose modifications). All changes to recommended dosing +regimen/schedule should be documented in the patient record. Documentation of patient +instructions for dosing changes should also be in source records. +Patients should be instructed to record the reason for any missed doses and report to +the investigator at the next visit. If a dose is vomited, that dose should not be replaced, +(and recorded as a vomited dose). +Compliance with therapy will be assessed at the beginning of each cycle. Patients will be +given a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of +study drug as provided by each study site. A copy of the patient diary will be provided to +sites in study materials. +8.1.3.4 + +Special Instructions for Unblinding + +Patients on study therapy and all site study staff will remain blinded as to the assignment +of everolimus or placebo. Patients who have not had progressive disease and remain on +study after 12 cycles are unblinded and continue fulvestrant alone (if originally +randomized to placebo) or in combination with everolimus (if originally randomized to +everolimus) at the same dose and schedule in the Continuation Phase. If an emergency +situation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted. +Emergency Unblinding for Patients during the Induction Phase (within Cycles 1-12): +Unblinding is a serious action that should be restricted in order to limit potential study +bias. The breaking of the blinding code in all cases will render the patient off-protocol. +The Medical Monitor for the study must be involved in the decision to unblind and must +grant approval for unblinding any individual. Requests for unblinding will only be +considered in the event of an emergency or severe adverse reaction where identification + +79 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +of the medication is considered important for the welfare of the patient, and the rationale +for unblinding is applicable to the situation. All patients should be provided emergency +medical care by the treating physician and appropriate therapies for the medical +emergency should be initiated prior to the request for unblinding. +For example, a Serious Adverse Event (SAE) possibly, probably or definitely related to +the study drug occurs during the trial and the treatment of the SAE would be influenced +by whether he/she received everolimus or placebo. Unblinding is typically not necessary +if the medical management of the patient would not be materially altered by knowledge +of the treatment assignment. In the event that accidental unblinding occurs, the Principal +Investigator should report the occurrence promptly to the Medical Monitor and document +the incident in the patient records. All unblinding will be recorded as a protocol deviation. +If a participant is in a life-threatening situation in which knowledge of the treatment is +crucial to care AND the Medical Monitor cannot be reached immediately, the PM should +be contacted to facilitate the unblinding process. A report including the unblinding details +will be generated after the patient has been unblinded and will be sent to the site for +documentation (refer to Study Reference Manual for Unblinding Process). Report +information will include but is not limited to: +• +• +• +• +• + +ID number of the participant whose treatment assignment was unblinded +Date of unblinding and reconciliation of study drug in site and patient records +Reason for unblinding, including initial SAE report +Person responsible for unblinding +List of persons who are unblinded (e.g. study staff) + +8.1.4 + +Side Effects + +The most common adverse reactions (incidence ≥ 10%) reported for everolimus include +stomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation, +vomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea. +The most commonly reported grade 3-4 adverse reactions (incidence ≥ 2%) reported for +everolimus include infections, stomatitis, fatigue, and pneumonitis. + +8.1.5 + +Investigational Product Records at Investigational Site(s) + +Investigational product dispensing record/inventory logs and copies of signed packing +lists must be maintained at the investigational site for everolimus. It is the responsibility +of the Investigator to ensure that a current record of investigational product disposition is +maintained at each study site where investigational product is stored and/or dispensed. +Records must comply with applicable regulations and guidelines, and should include: +• + +Amount received and placed in storage area. + +• + +Amount currently in storage area. + +• + +Label ID number or batch number. + +• + +Dates and initials of person responsible for each investigational product inventory +entry/movement. + +80 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +• + +Amount dispensed to and returned by each patient, including unique patient +identifiers. + +• + +Amount transferred to another area for dispensing or storage. + +• + +Non-study disposition (e.g., wasted, broken). + +• + +Amount returned to manufacturer, if applicable + +• + +Amount destroyed at study site, if applicable + +8.1.6 + +Return and Destruction of Investigational Product + +Investigational product should be maintained at the site for accountability purposes. +Sites will be referred to the study pharmacy manual for instructions regarding the return +or destruction of everolimus study drug supply (site’s drug destruction policy must be +reviewed and approved by PrECOG before any study drug can be destroyed at a site). +Patients will be instructed to return all blister packs (empty or partially used) to the study +center. + +8.2 + +Fulvestrant (Faslodex) +8.2.1 + +Packaging and Labeling + +Fulvestrant is commercially available and approved and is indicated for the treatment of +HR-positive metastatic breast cancer in postmenopausal women whose disease has +returned or progressed following antiestrogen therapy. +Investigators should review the approved Package Insert (PI) (http://www.faslodex.com/ +faslodex-prescribing-info/index.aspx) for full information on storage, handling, +preparation and stability. +Fulvestrant is supplied as: +One clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for +intramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50. +(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will +be required for one dose.) +The syringes are presented in a tray with polystyrene plunger rod and safety needles +(SafetyGlide™) for connection to the barrel. +Each injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and +Benzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release +rate modifier. + +81 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +8.2.2 +8.2.2.1 + +Handling and Dispensing + +Storage Requirements/Stability + +Refrigerate 2°-8°C (36°-46°F). To protect from light, store in the original carton until time +of use. +8.2.2.2 + +Preparation and Administration + +Fulvestrant should be disposed of or destroyed as per written institutional policies and +per recommendations in the current approved Package Insert. To help avoid infectious +diseases due to accidental needle sticks, contaminated needles should not be recapped +or removed, unless there is no alternative or that such action is required by a specific +medical procedure. +WARNING: - Do not autoclave safety needle before use. Hands must remain +behind the needle at all times during use and disposal. +Directions: +(Source: Faslodex® Package Insert 1621903 Rev 12/11) +• Remove the glass syringe barrel from tray and check that it is not damaged +• Remove perforated patient record label from syringe +• Peel open the safety needle outer packaging. +• Break the seal of the white plastic cover on the syringe luer connector to remove the +cover with the attached rubber tip cap (Figure 1). +• Twist to lock the needle to the luer container. +• Remove the needle sheath. Pull shield straight off needle to avoid damaging needle +point. +• Remove excess gas from the syringe. +• Administer intramuscularly slowly in the buttock. Administer injection following +package instruction. For user convenience, the needle ‘bevel up’ position is +orientated to the lever arm (Figure 3). +• Immediately activate needle protection device upon withdrawal from patient by +pushing lever arm completely forward until the tip is fully covered (Figure 2). +• Visually confirm that the lever arm has fully advanced and the needle tip is covered. +If unable to activate, discard immediately into an approved sharps collector. +Activation of the protective mechanism may cause minimal splatter of fluid that may +remain on the needle after injection. For greatest safety, use a one-handed +technique and activate away from self and others. +• If the 250 mg/5 mL formulation is used, repeat the above steps for the second +syringe. After single use, discard in an approved sharps collector in accordance with +applicable regulations and institutional policy. +• Review the official package insert for more information regarding the use of the +SafetyGlide Needle. + +82 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +8.2.3 + +Side Effects + +The most commonly reported adverse experiences in the Faslodex® treatment groups, +regardless of the investigator’s assessment of causality, were gastrointestinal symptoms +(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back +pain, vasodilatation (hot flushes), and pharyngitis. +Injection site reactions with mild transient pain and inflammation were seen with +Faslodex® and occurred in 7% of patients (1% of treatments) given the single 5 mL +injection (predominately European Trial) and in 27% of patients (4.6% of treatments) +given the 2 x 2.5 mL injections (North American Trial). +Other adverse events reported as drug-related and seen infrequently (<1%) include +thromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions +including angioedema and urticaria. Vaginal bleeding has been reported infrequently +(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal +therapy to treatment with Faslodex® If bleeding persists, further evaluation should be +considered. + +83 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +9 + +Statistical Considerations + +The efficacy endpoints will be assessed among all eligible patients who receive protocol +therapy. Safety endpoints will be assessed among all treated patients, regardless of +eligibility. + +9.1 + +Primary Efficacy Endpoint + +The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the +time from randomization to documented disease progression or death. Based on results +from the CONFIRM trial, median PFS among patients with AI-resistant disease on +fulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have +either relapsed while receiving adjuvant therapy with an aromatase inhibitor +(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an +aromatase inhibitor for metastatic disease. (Patients previously treated with two or more +prior cycles of fulvestrant are not eligible. Patients who have received one prior cycle +(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as +they meet other eligibility criteria). Randomization will be 1:1, stratified for balancing +purposes using ECOG performance status (0 vs. 1), presence of measurable disease +(yes vs. no), and prior chemotherapy (yes vs. no). +We hypothesize that the addition of everolimus to fulvestrant will result in an +improvement in median PFS to 9.2 months. A one-sided stratified logrank test with a +type I error rate of 10% will be used to evaluate whether the addition of everolimus +shows promising improvement in PFS relative to fulvestrant alone. To have 90% power +to detect the hypothesized improvement, enrollment of approximately 120 eligible +patients (60 per arm) and full information of 98 events (deaths or progressions) are +required. Allowing up to 10 patients to be ineligible or to not start study treatment, +approximately 130 patients will need to be enrolled. With accrual of approximately 130 +patients in 12 months, the required 98 events are expected to occur approximately 12 +months after accrual is completed. Other endpoints that will be evaluated include clinical +benefit rate (proportion stable or responding for at least 6 months), objective response +rate (CR+PR), time to progression (TTP; defined as the time from randomization until +progression of the disease), and overall survival (OS; defined as the time from +randomization until death or censored at the date of last follow-up). +PFS will be evaluated using the stratified log-rank test described above, as will TTP and +OS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints. +Clinical benefit rate and objective response rates will be compared between arms using +Fisher’s exact tests. 90% exact binomial confidence intervals on the rates will be +provided. + +9.2 + +Safety Analyses + +A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination +arm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each +arm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no +wider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%) +will be 96% on each arm. + +84 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +9.3 + +Analyses of Other Secondary Endpoints + +Other endpoints that will be evaluated include overall survival, time to progression, and +objective response rate. Overall survival will be characterized using Kaplan-Meier plots +and other descriptive metrics. The objective response rate will be provided for each arm, +with 90% exact binomial confidence intervals. Median time to progression will be +estimated for each arm. + +85 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +10 Adverse Event Reporting +10.1 Collection of Safety Information +Adverse Event (AE) is defined as any new untoward medical occurrence or worsening +of a pre-existing medical condition in a patient administered a medicinal product in a +clinical investigation and which does not necessarily have a causal relationship with this +treatment. An AE can therefore be any unfavorable and unintended sign (including an +abnormal laboratory finding, for example), symptom, or disease temporally associated +with the use of a product (investigational or marketed), whether or not considered related +to the product (investigational or marketed). Abnormal laboratory values or test results +constitute adverse events only if they induce clinical signs and symptoms, are +considered clinically significant, or require therapy. +Following written consent to participate in the study, all serious AEs should be collected +on a patient. The collection of non-serious AE information should begin at initiation of +therapy. +All identified AEs must be recorded and described on the appropriate page of the Case +Report Form (CRF). If known, the diagnosis of the underlying illness or disorder should +be recorded, rather than individual symptoms. The following information should be +documented for all AEs: date of onset and resolution, severity of the event; the +investigator’s opinion of the relationship to investigational product (see definitions +below); treatment required for the AE; cause of the event (if known); and information +regarding resolution/outcome. +Severity +CTCAE term (AE description) and grade: The descriptions and grading scales found +in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version +4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be +downloaded from the CTEP web site (http://ctep.cancer.gov). +All appropriate treatment areas should have access to a copy of the CTEP CTCAE +Version 4.0 (see Appendix E). +Attribution +The following categories and definitions of causal relationship or attribution to study drug +should be used to assess Adverse Events: +• + +Definite: There is a reasonable causal relationship between the study drug and the +event. The event responds to withdrawal of study drug (dechallenge) and recurs with +rechallenge, if clinically feasible. + +• + +Probable: There is a reasonable causal relationship between the study drug and the +event. The event responds to dechallenge. Rechallenge is not required. + +• + +Possible: There is a reasonable causal relationship between the study drug and the +event. Dechallenge information is lacking or unclear. + +• + +Unlikely: There is doubtful causal relationship between the study drug and the event. + +86 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +• + +Unrelated: There is clearly not a causal relationship between the study drug and the +event or there is a causal relationship between another drug, concurrent disease, or +circumstances and the event. + +Categories ‘Definite’, ‘probable’ and ‘possible’ are considered study drug related. +Categories ‘not likely’ and ‘not related’ are considered not study drug-related. +The development of a new cancer should be regarded as an AE. New cancers are those +that are not the primary reason for administration of study treatment and have been +identified after inclusion of the patient into the clinical study. +AEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days +after the last dose of study therapy (fulvestrant and/or everolimus/placebo) until ≤ +grade 1 or stabilization, and reported as SAEs if they become serious. Serious +adverse events >30 days after last dose of fulvestrant and/or everolimus/placebo +are not reported unless the event may be related to everolimus/placebo. + +10.2 Handling of Serious Adverse Events (SAEs) +10.2.1 SAE Definitions +A serious AE is any untoward medical occurrence occurring after informed consent is +granted or that at any dose: +• + +results in death, + +• + +is life-threatening (defined as an event in which the study patient was at risk of death +at the time of the event; it does not refer to an event which hypothetically might have +caused death if it were more severe), + +• + +requires inpatient hospitalization or causes prolongation of existing hospitalization, + +• + +results in persistent or significant disability/incapacity, + +• + +is a congenital anomaly/birth defect, + +• + +is an important medical event (defined as a medical event(s) that may not be +immediately life-threatening or result in death or hospitalization but, based upon +appropriate medical and scientific judgment, may jeopardize the patient or may +require intervention (e.g., medical, surgical) to prevent one of the other serious +outcomes listed in the definition above.) +Examples of such events include, but are not limited to, intensive treatment in an +emergency room or at home for allergic bronchospasm; blood dyscrasias or +convulsions that do not result in hospitalization. + +10.2.2 SAE Reporting Requirements +All serious adverse events require expeditious handling and reporting to comply with +regulatory requirements. The Principal Investigator has the obligation to report all +serious adverse events to PrECOG, or their designee. A study specific SAE form to be +utilized for SAE reporting will be provided with supplemental study materials. + +87 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +All serious adverse events that occur either during the study period (Induction and/or +Continuation) or within 30 days of discontinuation of dosing regardless of event +relationship to the study medications (fulvestrant and/or everolimus/placebo) should be +reported to PrECOG, or their designee within 24 hours of the investigator’s knowledge of +the event or, when the event occurs on a weekend or national holiday, at the latest on +the following working day. All deaths during treatment or within 30 days following +completion of active protocol therapy must be reported. Serious adverse events that +occur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged +related to the everolimus/placebo (definitely, probably or possibly) must be reported to +PrECOG, or their designee using the 24 hour timeline noted above. If only limited +information is initially available, follow-up reports are required. Serious adverse events +that occur >30 days from last dose of fulvestrant and are judged to be related to +fulvestrant will follow normal reporting mechanisms for commercial drugs. +SAE Hotline Phone Number: +610-354-0404 during normal business hours (8:30 AM – 5 PM EST) +484-574-2367 after normal business hours (after 5 PM EST) +SAE Fax Number: +888-801-8795 +PrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department +(DS&E) of all SAE’s within 24 hours of the Awareness Date. Relevant follow-up +information will be provided to Novartis DS&E as soon as it becomes available. +In addition, Investigators should also report event(s) to their IRB as required. +Collection of complete information concerning SAEs is extremely important. Full +descriptions of each event will be followed. Thus, follow-up information which becomes +available as the SAE evolves, as well as supporting documentation (e.g., hospital +discharge summaries and autopsy reports), should be collected subsequently, if not +available at the time of the initial report, and immediately sent using the same procedure +as the initial SAE report. The original and all follow-up SAEs form must be kept on file at +the study site. +For Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious +adverse experiences will be forwarded to the product manufacturer by PrECOG (or their +designee), if applicable. + +10.3 Reporting of Second Primary Cancers +New cancers are those that are not the primary reason for administration of study +treatment and have been identified after inclusion of the patient into the clinical study. +All cases of new primary cancers that occur during or after protocol treatment must be +reported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol +treatment. Secondary primary malignancies should also be reported as a SAE. This form +is not for use for reporting recurrence or development of metastatic disease. A copy of +the pathology report, if applicable, should be sent, if available. +Note: Once data regarding survival and remission status are no longer required by the +protocol, no follow-up data should be submitted, including the PrECOG Second Primary +Form. + +88 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +11 Administrative +11.1 Protocol Compliance +The study shall be conducted as described in this protocol. All revisions to the protocol +must be discussed with, and be prepared by PrECOG and/or representatives. The +Investigator should not implement any deviation or change to the protocol or consent +without prior review and documented approval from PrECOG and/or representatives and +the IRB of an amendment, except where necessary to eliminate an immediate hazard(s) +to study patients. +If a deviation or change to the approved protocol is implemented to eliminate an +immediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the +IRB for review and approval as soon as possible afterward. Documentation of approval +signed by the chairperson or designee of the IRB(s) should be in the study records. If +PrECOG and/or representatives provides an amendment that substantially alters the +study design or increases the potential risk to the patient; the consent form must be +revised and submitted to the IRB(s) for review and approval; the revised form must be +used to obtain consent from patients currently enrolled in the study if they are affected +by the amendment; and the new form must be used to obtain consent from new patients +prior to study entry. Information as to who investigators should send correspondence will +be provided in additional study documents. + +11.2 Institutional Review Board +Before study initiation, the Investigator must have written and dated approval from their +respective IRB for the protocol, consent form, patient recruitment materials/process and +any other written information to be provided to patients. The Investigator should also +provide the IRB with a copy of the Investigator Brochure or product labeling, and any +updates. +The Investigator should provide the IRB with reports, updates, and other information +(e.g., Safety Updates, amendments, and administrative letters) according to regulatory +requirements, IRB or study site procedures. + +11.3 Informed Consent Procedures +Investigators must ensure that patients who volunteer for clinical trials or their legally +acceptable representative are clearly and fully informed about the purpose, potential +risks and other information. +A protocol specific informed consent form (ICF) template will be provided to sites. +Preparation of the site-specific consent form is the responsibility of the site Investigator +and must include all applicable regulatory and IRB requirements, and must adhere to +Good Clinical Practice (GCP) and to the ethical principles that have their origin in the +Declaration of Helsinki. All changes to the ICF template will be approved by PrECOG +and/or their representatives prior to implementation. +In accordance with the Health Information Portability and Accountability Act (HIPAA), the +consent process will also include written authorization by patients to release medical +information to allow PrECOG and/or its agents, regulatory authorities, and the IRB of +89 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +record at the study site for access to patient records and medical information relevant to +the study, including the medical history. This will be documented in the informed consent +form or other approved form obtained at the time of informed consent per institutional +policies. This form should also be submitted to PrECOG and/or its agents for review +prior to its implementation. +The Investigator must provide the patient or legally acceptable representative with a +copy of the consent form and written information about the study in the language in +which the patient is most proficient. The language must be non-technical and easily +understood. The Investigator should allow time necessary for patient or patient's legally +acceptable representative to inquire about the details of the study, then informed +consent must be signed and personally dated by the patient or the patient's legally +acceptable representative and by the person who conducted the informed consent +discussion. The patient or legally acceptable representative should receive a copy of the +signed informed consent and any other written information provided to study patients +prior to patient's participation in the trial. The investigator is responsible for assuring +adequate documentation of this process and for storage and maintenance of the original +signed consent form for each patient/subject. +The informed consent and any other information provided to patients or the patient's +legally acceptable representative, should be revised whenever important new +information becomes available that is relevant to the patient's consent, and should +receive IRB approval prior to use. The Investigator, or a person designated by the +Investigator should inform the patient or the patient's legally acceptable representative of +all pertinent aspects of the study and of any new information relevant to the patient's +willingness to continue participation in the study. This communication should be +documented in the patient record. During a patient's participation in the trial, any updates +to the consent form and any updates to the written information will be provided to the +patient. + +11.4 Safety Communication +Investigators will be notified of all AEs that are serious, unexpected, and definitely, +probably, or possibly related to the investigational product. Upon receiving such notices, +the Investigator must review and retain the notice with the Investigator Brochure and +submit a copy of this information to the Institutional Review Board (IRB) according to +local regulations. The Investigator and IRB will determine if the informed consent +requires revision. The Investigator should also comply with the IRB procedures for +reporting any other safety information. All revisions should be submitted to PrECOG +and/or agents for review. + +11.5 Monitoring +Representatives and agents of PrECOG and, as applicable to the study, the +manufacturer of Investigational Product must be allowed to visit all study site locations +periodically to assess the data, quality and study integrity. The purpose of this visit is to +review study records and directly compare them with source documents and discuss the +conduct of the study with the Investigator, and verify that the facilities remain acceptable. +The study may be evaluated by other auditors and government inspectors who must be +allowed access to electronic Case Report Forms (eCRFs), source documents and other +90 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +study files. The investigator must notify PrECOG of any scheduled visits by regulatory +authorities, and submit copies of all reports. Information as to who investigators should +notify of an audit or where to address questions will be provided in additional study +materials. Monitoring of drug accountability will also occur. + +11.6 Study Records +An Investigator is required to maintain adequate regulatory files with corresponding +communication and approvals, accurate histories, observations and other data on each +individual treated. Full details of required regulatory documents will be provided in +additional study materials. Data reported on the eCRF must be consistent with the +source documents as part of the patient record. +The confidentiality of records that could identify patients must be protected, respecting +the privacy and confidentiality rules in accordance with the applicable regulatory +requirement(s). +A study specific signature record will be maintained to document signatures and initials +of all persons at a study site who are authorized to make entries and/or corrections on +eCRFs as well as document other study-specific roles. + +11.7 Electronic Case Report Form (eCRF) Information +Additional information regarding eCRF instructions, timelines for data entry/submission +and query completion can be found in supplemental materials provided to the site. Sites +will be expected to complete eCRFs as per the schedule provided and submit all +relevant data as per the specified timelines. All items recorded on eCRFs must be found +in source documents. +The completed eCRF must be promptly reviewed, electronically signed, and dated by a +qualified physician who is an Investigator or Sub-Investigator. +Instructions for management of patients who do not receive any protocol therapy: +If a patient is randomized and does not receive any assigned protocol treatment, +baseline, Serious Adverse Event and follow-up data will still be entered and must be +submitted according to the eCRF instructions. Document the reason for not starting +protocol treatment on the appropriate electronic off-treatment form. + +11.8 Records Retention +FDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related +documentation, including source documents for the periods described below for studies +performed under a US IND: +• +• +• + +two years after the FDA approves the marketing application, or +two years after the FDA disapproves the application for the indication being studied, +or +two years after the FDA is notified by the sponsor of the discontinuation of trials and +that an application will not be submitted. + +The Investigator must retain investigational product disposition records, copies of eCRFs +(or electronic files), and source documents for the maximum period required by + +91 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +applicable regulations and guidelines, or Institution procedures, whichever is longer but +not less than 5 years from the completion of the study. The Investigator must contact +PrECOG and/or representatives prior to destroying any records associated with the +study. +Information as to who investigators should contact for questions will be provided in +additional study documents. PrECOG and/or representatives will notify the Investigator +when the trial records for this study are no longer needed. + +92 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +12 Glossary of Terms and List of Abbreviations +Term + +Definition + +4E-BP1 + +4E-Binding Protein + +Ab +ADPKD + +Antibodies +Autosomal Dominant Polycystic Kidney Disease + +ADR + +Adverse Drug Reaction + +AE(s) + +Adverse Events(s) + +Akt/PKB + +Protein Kinase B + +AI + +Aromatase Inhibitor + +Alk Phos + +Alkaline Phosphatase + +ALT/SGPT +AMD + +Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase +Age-Related Macular Degeneration + +ANC + +Absolute Neutrophil Count + +ASCO-CAP + +American Society of Clinical Oncology-College of American Pathologist + +AST/SGOT + +Aspartate +Aminotransferase/Glutamic +Glutamic-Oxaloacetic Transaminase + +AUC +°C + +Area Under the Concentration-Time Curve +degrees Celsius + +Ca + +Calcium + +CBC + +Complete Blood Count + +CBR + +Clinical Benefit Rate + +CI + +Confidence Interval + +CISH + +Chromogenic In Situ Hybridization + +Cl + +Chloride + +cm +Cmax + +centimeter +Maximum plasma concentration + +CO2 + +Carbon Dioxide + +CoA + +Coenzyme A + +COPD + +Chronic Obstructive Pulmonary Disease + +CPK + +Creatine Phosphokinase + +CR + +Complete Response + +CRC + +Colorectal Cancer + +Creat + +Creatinine + +CRF + +Case Report Form + +CRO + +Contract Research Organization + +CT + +Computer Tomography + +CTC + +Common Toxicity Criteria + +93 + +Oxaloacetic + +Transaminase/Serum + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Term + +Definition + +CTCAE + +The CTEP Common Terminology Criteria for Adverse Events (CTCAE) + +CTEP + +Cancer Therapy Evaluation Program + +CYP3A4 + +CytochromeP450 3A4 Isoenzyme + +DLBCL + +Diffuse Large B Cell Lymphoma + +DLCO + +Diffusing Capacity of the Lung for Carbon Monoxide + +DLT + +Dose Limiting Toxicity + +DNA + +Deoxyribonucleic Acid + +DS&E + +Drug Safety and Epidemiology + +eCRF +e.g. +ER + +Electronic Case Report Form +exempli gratia (for example) +Estrogen Receptor + +FSH +EU +FDA + +Follicle Stimulating Hormone +European Union +Food and Drug Administration +Fluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography + +FDG-PET +FISH +FKBP-12 +FSH + +Fluorescence In Situ Hybridization +FK506-Binding Protein 12 +Follicle Stimulating Hormone + +GBM + +Glioblastoma Multiforme + +GCP + +Good Clinical Practice + +GEP-NET + +Gastroenteropancreatic Neuroendocrine Tumor + +GERD + +Gastroesophageal Reflux Disease + +GF + +Growth Factor + +GI + +Gastrointestinal + +GnRH + +Gonadotropin-Releasing Hormone + +HBV + +Hepatitis B Virus + +HBcAb + +Hepatitis B core Antibodies + +HBsAb + +Hpatitis B surface Antibodies + +HbsAg + +Hepatitis B surface Antigen + +HCC + +Hepatocellular Cancer + +HCV + +Hepatitis C Virus + +HER-2 + +Human Epidermal Growth Factor Receptor 2 + +HIF-1 + +Hypoxia-Inducible Factor-1 + +HIPAA + +Health Information Portability and Accountability Act + +HIV + +Human Immunodeficiency Virus + +HMG + +3-hydroxy-3-methyl-glutaryl + +HR + +Hormone-Receptor + +HUVECS + +Human Umbilical Endothelial Cells + +IB + +Investigator Brochure (also called Investigator Drug Brochure, IDB) + +94 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Term + +Definition + +ICF + +Informed Consent Form + +ICH + +International Conference on Harmonization + +IND +INN + +Investigational New Drug +International Non-Proprietary Name + +INR + +International Normal Ratio + +IRB +IU + +Institutional Review Board +International Unit + +IV + +Intravenous + +IWR + +Interactive Web Randomization + +K + +Potassium + +kg + +Kilogram + +L + +Liter + +LDH + +Lactate Dehydrogenase + +LDL + +Low-Density Lypoproteins + +LFTs + +Liver Function Tests + +LLN + +Lower Limit Normal + +LMW +Log10 + +Low Molecular Weight +Decadic logarithm (common logarithm) + +M + +Meter + +mg +Mg + +Milligram +Magnesium + +min + +minute + +mL + +Milliliter + +mRCC + +Metastatic Renal Cell Carcinoma + +MRI + +Magnetic Resonance Imaging + +mTOR + +mammalian Target of Rapamycin + +N +Na + +Number of patients or observations +Sodium + +N/A + +Not Applicable + +NCI + +National Cancer Institute + +NSCLC + +Non-Small Cell Lung Cancer + +Ng + +Nanogram + +µM +Nm + +Nanometer + +nM + +Nanomolar + +OS + +Overall Survival + +PD + +Progressive Disease +Phosphoinositide 3-kinase + +P13K + +Micromolar + +95 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Term + +Definition + +PI + +Package Insert + +PBMC + +Peripheral Blood Mononuclear Cells + +PCR +PET + +Polymerase Chain Reaction +Proton Emission Tomography + +PFS +PgP + +Progression Free Survival +P-glycoprotein + +PK + +Pharmacokinetic + +Plt + +Platelet + +PNET + +Pancreatic Neuroendocrine Tumor + +PO +PR + +Per Oral (by mouth route of administration) +Partial Response + +PR-positive + +Progesterone Receptor + +PSA + +Prostate-Specific Antigen + +PTEN + +Phosphatase and Tensin Homolog Deleted on Chromosome 10 + +PT/PTT + +Prothrombin Time/Partial Thromboplastin Time + +QC +QD + +Quality Control +Once Daily +the interval between the beginning of the Q-wave and the end of the T-wave on +an electrocardiogram + +QT +QTc + +corrected Q to T wave interval on electrocardiogram + +RCC +RECIST +RNA + +Renal Cell Carcinoma +Response Evaluation Criterion Solid Tumors +Ribonucleic Acid +Response Rate + +RR +RTK +S6K1 +SAE +SC +SCLC +SD +SEGA +SERD + +Receptor Tyrosine Kinase +S6 Kinase 1 +Serious Adverse Event +Subcutaneous +Small Cell Lung Cancer +Stable Disease +Subependymal Giant Cell Astrocytoma +Selective Estrogen Receptor Down-Regulators + +SERM + +Selective Estrogen Receptor Modulator + +T Bili +TKI + +Total Bilirubin +Tyrosine Kinase Inhibitor + +TS + +Tuberous Sclerosis + +TSC + +Tuberous Sclerosis Complex + +TTP + +Time to Progression + +96 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Term + +Definition + +TUNNEL + +Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End +Labeling + +µg + +microgram + +ULN + +Upper Limit Normal + +US + +United States + +USP +VEGF + +United States Pharmacopeia +Vascular Endothelial Growth Factor + +WBC + +White Blood Cell Count + +WHO + +World Health Organization + +97 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +13 Appendix A: Eligibility Checklist + + +Pt Initials: ___ ___ ___ +F + +M + +L + +Study Personnel: ____________________________ +Date of Evaluation: ___/___/____ + +INCLUSION CRITERIA +Must be willing to sign a protocol-specific informed consent. +Consent Date: _____/_____/_____ + +Consent in patient record + +Age > 18 and female. +Birth Date: _____/_____/_____ + +Documentation in patient record + +ECOG Performance Status 0 or 1. +PS + +0 + +1 + +(must document in patient record) + +Patient must have histologically or cytologically confirmed adenocarcinoma of the breast. +Pathology Date: _____/_____/______ + +Pathology must be in patient record + +Must have stage IV disease or inoperable locally advanced disease. +Documentation in patient record (via imaging scans as per RECIST Section 6.0) +Patients must have ER and/or PR-positive disease as determined by their local pathology or +51 +reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal +52 +by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria. +ER+ + +PR+ + +ER+ and PR+ + +Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies +Pathology Date: _____/_____/______ + +Pathology must be in patient record + +Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor +(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase +inhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g., +Tamoxifen) between the time of progression on an AI and registration. +Documentation in patient record +Patients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients +who have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of +randomization are eligible as long as they meet other eligibility criteria. +Documentation in patient record +Patients must be post menopausal. (see Section 3.1) +Documentation in patient record + +98 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + + +Pt Initials: ___ ___ ___ +F + +M + +L + +Study Personnel: ____________________________ +Date of Evaluation: ___/___/____ + +Patient may have received up to one prior systemic chemotherapy regimen for metastatic +disease. +no prior systemic chemotherapy +one prior systemic chemotherapy regimen +documentation in patient record +Adequate end organ function, as evidenced by the following obtained within 4 weeks of +randomization: all must be present (see Section 7.0 for labs that may need to be repeated within +≤ 7 days of Cycle 1, Day 1) +9 + +Total White Blood Cell Count (leucocytes, WBC) ≥ 3.0 x 10 /L, absolute neutrophil count +9 +9 +(ANC) ≥ 1.5 x 10 /L and platelet count ≥ 100 x 10 /L +(Total WBC value:_________unit__________) +(ANC value:_________unit__________) +(Platelet Count value:_________unit__________) +Hemoglobin ≥ 9 g/dL +(value:_________unit___________) +Serum Bilirubin ≤ 1.5 x ULN +(value:_________unit___________ULN_______) +AST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases) +(AST value:_________unit___________ULN_______) +(ALT value:_________unit___________ULN_______) +Serum Creatinine ≤ 1.5 x ULN (value:_________unit___________ULN_______) +Serum Albumin ≥ 3 g/dL +(value:_________unit__________) +Fasting Serum Cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND Fasting Triglycerides ≤ 2.5 x +ULN Note: In case one or both of these thresholds are exceeded, the patient can only be +included after initiation of appropriate lipid lowering medication. +(Fasting Serum Cholesterol value:_________unit__________) +(Fasting Triglycerides value:_________unit___________ULN_______) +PT with INR ≤ 1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin +or on a stable dose of low molecular weight heparin for >2 weeks at time of randomization. +(INR value:_________unit___________) +(PT value:_________unit___________) +Documentation in patient record + +99 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + + +Pt Initials: ___ ___ ___ +F + +M + +L + +Study Personnel: ____________________________ +Date of Evaluation: ___/___/____ + +Patients may have measurable disease, non-measurable disease (e.g., bone only metastases), +or both. Response and progression will be evaluated in this study using the new international +criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) +guideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those +that can be accurately measured in at least one dimension (longest diameter to be recorded) as +≥ 20 mm by chest x-ray, as ≥ 10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All +tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). +Measurable disease only +Non-measurable disease only +Both measurable and non-measurable disease +Documentation in patient record +Note: Tumor lesions in a previously irradiated field are not considered measurable. +Patients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix +within the past five years must have been treated with curative intent. Patients with a history of +prior malignancy are eligible provided they were treated with curative intent and have been free +of disease for >3 years. +N/A + +Date of treatment: _____/_____/_____ + +Documentation in patient record + +EXCLUSION CRITERIA +Patients who have had any major surgery or significant traumatic injury within 4 weeks of +randomization, or have not recovered from the side effects of any major surgery (defined as +requiring general anesthesia) or patients that may require major surgery during the course of the +study are not eligible. (Placement of vascular access device will not be considered major +surgery.) +Date of surgery: _____/_____/_____ + +N/A + +Documentation in patient record + +Patients may not be receiving any other investigational agents or have received any +investigational agent within 4 weeks of randomization. +Date of last treatment: _____/_____/_____ + +N/A + +Documentation in patient record + +Patients must not be receiving any concomitant anticancer treatment or have received anticancer +treatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody +based therapy, e.g.), with the following exceptions: +• Bisphosphonates, Zometa or Xgeva for bone metastases +• Hormonal therapy (e.g., AI, Tamoxifen) +• a GnRH analog is permitted if the patient had progressive disease on a GnRH analog +plus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be +discontinued. +Date of last treatment: _____/_____/_____ + +N/A + +100 + +Documentation in patient record + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + + +Pt Initials: ___ ___ ___ +F + +M + +L + +Study Personnel: ____________________________ +Date of Evaluation: ___/___/____ + +Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, +everolimus). +N/A + +Documentation in patient record + +Patients must not be receiving chronic, systemic treatment with corticosteroids or another +immunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily. +Topical or inhaled corticosteroids are allowed. +N/A + +Documentation in patient record + +Patients must not receive immunization with attenuated live vaccines within one week of +randomization or during the study period. Close contact with those who have received attenuated +live vaccines should be avoided during treatment with everolimus. Examples of live vaccines +include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella +and TY21a typhoid vaccines. +N/A + +Documentation in patient record + +Patients must not have current or a prior history of brain metastases or leptomeningeal disease. +Patients must not have rapidly progressive, life-threatening metastases. This includes patients +with extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic +metastases. +N/A + +Documentation in patient record + +Patients must not have a known hypersensitivity/history of allergic reactions attributed to +compounds of similar chemical or biologic composition to everolimus (or other rapamycins such +as sirolimus, temsirolimus) or fulvestrant. +N/A + +Documentation in patient record + +Since everolimus may cause bone marrow suppression, patients with congenital or acquired +immune deficiency at increased risk of infection are not eligible. This includes patients being +treated with chronic immunosuppressive agents (including greater than or equal to 5 mg +prednisone or its equivalent daily), and patients with known HIV seropositivity. +N/A + +Documentation in patient record + +Patients must not have any impairment of gastrointestinal function or gastrointestinal disease +that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled +nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). +N/A + +Documentation in patient record + +Patients must not have an active, bleeding diathesis. +N/A + +Documentation in patient record + +101 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + + +Pt Initials: ___ ___ ___ +F + +M + +L + +Study Personnel: ____________________________ +Date of Evaluation: ___/___/____ + +Patients must not have a history of any condition or uncontrolled intercurrent illness including, +but not limited to, ongoing or active infection or psychiatric illness/social situations that in the +opinion of the investigator might intefere with or limit the patient’s ability to comply with the +protocol or pose additional or unacceptable risk to the patient. +N/A + +Documentation in patient record + +Patients must not have any severe and/or uncontrolled medical conditions or other conditions +that could affect their participation in the study such as: +• + +Symptomatic congestive heart failure of New York Heart Association Class III or IV (see +Appendix D) + +• + +Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious +uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease + +• + +History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g. +COPD) requiring treatment. Such patients would be eligible if PFTs performed within 8 +weeks of treatment noted a DLCO greater than 50%. + +• + +Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal +glycemic control should be achieved before starting trial therapy.) + +• + +Active (acute or chronic) or uncontrolled severe infections + +• + +Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C). + +Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at +screening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all +patients with a positive medical history based on risk factors and/or confirmation of prior +HBV/HCV infection. +N/A + +Documentation in patient record + +102 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +14 Appendix B: ECOG Performance Status Scale +Grade ECOG +0 + +Fully active, able to carry on all pre-disease performance without restriction + +1 + +Restricted in physically strenuous activity but ambulatory and able to carry out +work of a light or sedentary nature, e.g., light house work, office work + +2 + +Ambulatory and capable of all self-care but unable to carry out any work +activities. Up and about more than 50% of waking hours + +3 + +Capable of only limited self-care, confined to bed or chair more than 50% of +waking hours + +4 + +Completely disabled. Cannot carry on any self-care. Totally confined to bed or +chair + +5 + +Dead + +61 + +Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair + +103 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +15 Appendix C: Medications that can Inhibit/Induce CYP3A4 +and PgP +See Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines +on use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors +and inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug +interactions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A. +Table 15-0 +Clinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme +CYP3A +INHIBITORS +Strong Inhibitors: +clarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir, +mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, +tipranavir, troleandamycin, voriconazole +(Krishna et al, 2009) +Moderate Inhibitors: +aprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem, +dronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit +juice), imatinib, tofisopam, verapamil +INDUCERS +amprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine, +dexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine, +oxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin, +ritonavir, rufinamide, St. John’s wort, talviraline, tipranavir, topiramate, troglitazone + +104 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +Table 15-1 +Clinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP +and PgP/CYP3A +SUBSTRATES +Colchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine +INDUCERS +Rifampin, St. John’s wort +PgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS +Amiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone, +elacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir, +itraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine, +quercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John’s wort +(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil +Reference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated +Oct. 2, 2011, which summarizes DDI data from three sources including the FDA’s +“Guidance for Industry, Drug Interaction Studies”, the University of Washington’s Drug +Interaction Database, and Indiana University School of Medicine's Drug Interaction +Table. + +105 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +16 Appendix D: New York Heart Association (NYHA) Cardiac +Classification of Functional Capacity and Objective +Assessment +In 1928 the New York Heart Association published a classification of patients with cardiac +disease based on clinical severity and prognosis. This classification has been updated in seven +subsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and +Great Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the +American Heart Association, New York City Affiliate, was released March 4, 1994*. The new +classifications are summarized below. +The NYHA classification system relates symptoms to everyday activities and the patient’s quality +of life. + +Class + +Symptoms + +Class I + +Patients with cardiac disease but without resulting limitation of physical +activity. Ordinary physical activity does not cause undue fatigue, +palpitation, dyspnea (shortness of breath), or anginal pain. + +Class II + +Patients with cardiac disease resulting in slight limitation of physical +activity. Comfortable at rest, but ordinary physical activity results in +fatigue, palpitation, dyspnea or anginal pain. + +Class III + +Patients with cardiac disease resulting in marked limitation of physical +activity. Comfortable at rest, but less than ordinary activity causes +fatigue, palpitation, dyspnea or anginal pain. + +Class IV + +Patients with cardiac disease resulting in inability to carry out any +physical activity without discomfort. Symptoms of heart failure or anginal +syndrome may be present even at rest. If any physical activity is +undertaken, discomfort increases. + +Objective Assessment +I: + +No objective evidence of cardiovascular disease + +II: + +Objective evidence of minimal cardiovascular disease + +III: + +Objective evidence of moderately severe cardiovascular disease + +IV: + +Objective evidence of severe cardiovascular disease + +Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712 +The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of +Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256. + +106 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +17 Appendix E: CTEP Common Terminology Criteria for +Adverse Events (CTCAE) Version 4.0 +Common Terminology Criteria for Adverse Events (CTCAE) +CTCAE term (AE description) and grade: The descriptions and grading scales found +in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version +4.0 will be utilized for AE reporting. All appropriate treatment areas should have access +to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be +downloaded from the CTEP web site (http://ctep.cancer.gov). +All appropriate treatment areas should have access to a copy of the CTEP CTCAE +Version 4.0. + +107 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +18 Appendix F: Patient Pill Diary +Copies of this form will be made available to study staff in study materials. This form is +appended as an example only, and may be modified during the study. + +Site Instructions: +1. If this or a similar diary is used this may be considered source documentation, if the +diary has been reviewed and signed by a member of the study staff. Patient +compliance with protocol therapy can be assessed using a pill record or by other +documentation in the patient record. +2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with +each cycle being 28 days. +3. If a dose modification occurs, patients should be given instructions for dosing, and +the form can be modified as appropriate. Any dose changes should be recorded in +the patient chart with appropriate rationale as per protocol. +4. A new form can be used at any time during a cycle; as long as the patient is made +aware of changes (e.g. study staff fills in dates and mark lines/dates not to be used). +5. It is the responsibility of the investigator to appropriately dispense and monitor study +medications and to comply with the protocol. + +108 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 +Patient Name: _____________________________ + +Patient Study ID (filled in by Site Staff): +______________________ + +Patient Instructions: +1. Complete each form as instructed by your physician or study nurse. +2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the +morning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose. +Otherwise just skip that dose and begin as usual the next day. Please mark dates of any missed +pills on your record. +3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food. +The tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets +should be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of +water should be put into a glass. The tablets should then be added and the contents stirred gently +(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk. +If you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to +take the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose +and begin as usual the next day. +4. If you have any side effects or comments, please note in the comment section or on the back of the +page. For questions or if you have any side effects that should be immediately reported to your +study doctor, please call _______________________________at: (_____) _____ - _________. +5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If +your dose changes, the study nurse or doctor will let you know. You should note this on the form. +Date + +Day + +# Pills + +Comments + +Date + +Day + +1 +2 + +15 +16 + +3 + +17 + +4 + +18 + +5 + +19 + +6 + +20 + +7 + +21 + +8 + +22 + +9 + +23 + +10 + +24 + +11 + +25 + +12 + +26 + +13 + +27 + +14 + +28 + +Patient Signature: _________________________________ + +# Pills + +Comments + +Date: ___________________ + +Physician Office to complete this section: +Study Personnel Signature: __________________________ + +109 + +Date: ____________________ + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +19 References +1. +Moy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy +and new therapeutic approaches. Clin Cancer Res 2006;12:4790-3. +2. +Nicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in +human malignancy. Cell Signal 2002;14:381-95. +3. +DeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid +restores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol +2003;14:1051-6. +4. +Tokunaga E, Kataoka A, Kimura Y, et al. The association between Akt +activation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer +2006;42:629-35. +5. +Beeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA. +Akt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling. +Ann Oncol 2007;18:1323-8. +6. +Perez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a +worse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5. +7. +Bjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat +Rev Cancer 2004;4:335-38. +8. +Shaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell +growth. Nature 2006;441:424-30. +9. +deGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity +restores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin +Cancer Res 2004;10:8059-67. +10. +Awada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001 +(everolimus) in combination with letrozole in patients with advanced breast cancer: +results of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91. +11. +American Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta: +American +Cancer +Society +Inc.; +http://www.cancer.org/acs/groups/content/@ +epidemiologysurveilance/documents/document/acspc-030975.pdf +(accessed 7/11/2012) +12. +Buzdar AU. Endocrine therapy in the treatment of metastatic breast cancer. +Semin Oncol 2001;28:291-304. +13. +Campos SM, Winer EP. Hormonal therapy in postmenopausal women with +breast cancer. Oncology 2003;64:289-99. +14. +Sparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and +prevention. New York: Marcel Dekker; 2002. +15. +Winer EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology +technology assessment on the use of aromatase inhibitors as adjuvant therapy for +postmenopausal women with hormone receptor-positive breast cancer: status report +2004. J Clin Oncol 2005;23:619-29. +16. +Berry J. Are all aromatase inhibitors the same? A review of controlled clinical +trials in breast cancer. Clin Ther 2005;27:1671-84. +110 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +17. +Howell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI +182,780, is as effective as anastrozole in postmenopausal women with advanced +breast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403. +18. +Osborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial +comparing the efficacy and tolerability of fulvestrant versus anastrozole in +postmenopausal women with advanced breast cancer progressing on prior endocrine +therapy: results of a North American trial. J Clin Oncol 2002;20:3386-95. +19. +Mauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK. +Fulvestrant (Faslodex®) versus anastrozole for the second-line treatment of advanced +breast cancer in subgroups of postmenopausal women with visceral and non-visceral +metastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833. +20. +Howell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus +tamoxifen for the treatment of advanced breast cancer in postmenopausal women +previously untreated with endocrine therapy: a multinational, double-blind, randomized +trial. J Clin Oncol 2004;22:1605-13. +21. +Ingle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced +breast cancer after progression on prior aromatase inhibitor therapy: North Central +Cancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6. +22. +Perey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in +postmenopausal women with advanced breast cancer and primary or acquired +resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical +Cancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9. +23. +Chia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo +controlled trial of fulvestrant compared with exemestane after prior nonsteroidal +aromatase inhibitor therapy in postmenopausal women with hormone receptor-positive, +advanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70. +24. +Di Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III, +Randomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500 +mg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast +Cancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600. +25. +Boulay A, Lane HA. The mammalian target of rapamycin kinase and tumor +growth inhibition. Recent Results Cancer Res 2007;172:99-124. +26. +Wullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism. +Cell 2006;124(3):471-84. +27. +Manning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell +2007;129(7):1261-74. +28. +Wang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1 +kinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem +2007;282(27):20036-44. +29. +Witzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent +temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005; +23(23):5347-56. +111 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +30. +Lane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus) +has antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor. +Clin Cancer Res 2009;15(5):1612-22. +31. +Mabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian +cancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in +an ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70. +32. +Galanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group +Study. J Clin Oncol 2005;23:5294-304. +33. +O’Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of +the mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further +Proposals. Tran Oncol; 2010 Apr; 3(2):65-79. +34. +Huang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel +antitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304. +35. +Zitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001 +(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine +tumor cells. Neuroendocrinology 2007;85(1):54-60. +36. +Zeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce +mTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12. +37. +Haritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP. +Antiproliferative activity of RAD001 (everolimus) as a single agent and combined with +other agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9. +38. +Ikezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of +PI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult +T-cell leukemia cells. Leuk Res 2007;31(5):673-82. +39. +Wanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition +induces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises +DLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84. +40. +Tuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil +sensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to +standard chemotherapy? Eur Surg Res 2007;39(6):380-7. +41. +Treeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment +with mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human +cancer cells. Gynecol Oncol 2006;102(2):292-9. +42. +Sieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin +pathway activity in hepatocellular carcinomas of patients undergoing liver +transplantation. Transplantation 2007;83(4):425-32. +43. +Lu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically +applicable strategies for overcoming trastuzumab resistance caused by PTEN +deficiency. Clin Cancer Res 2007;13(9):5883-8. +44. +Torres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M. +Targeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the +mammary gland. Cancer Res 2006;66(23):11381-8. +112 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +45. +Rossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic +intervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U +S A 2006;103(34):12843-8. +46. +Lane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic / +pharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the +oral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A. +47. +Tabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of +the mammalian target of rapamycin pathway with everolimus: A phase I tumor +pharmacodynamic study in patients with advanced solid tumors. J Clin Oncol +2008;28:10. +48. +http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965 +.htm (accessed 8/1/2012) +49. +Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal +hormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb +9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876 +50. +Sanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined +phosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21. +51. +Hammond ME, Hayes DF, Wolff AC, et al. American society of clinical +oncology/college of American pathologists guideline recommendations for +immunohistochemical testing of estrogen and progesterone receptors in breast cancer. +Oncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID: +21037871. +52. +Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical +Oncology/College of American Pathologists guideline recommendations for human +epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan +1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of +American Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.) +PMID: 17159189. +53. +Yeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with +hepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol +2004;15:1661-6. +54. +Loomba R, Rowley A, Wesley R, et al. Systematic review: the effect of +preventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med +2008;148(7):519-28. +55. +Divers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with +mTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast +Cancer: Clinical Experiences from a Single Center. Presented at the 38th Annual +Oncology Nurses’ Society Congress, April 25-28, 2013. Novartis Internal +Communication. +56. +Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria +in solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847. +57. +Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for +phase II clinical trials in androgen-independent prostate cancer: recommendations from +the Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7. +113 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +58. +Scher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for +patients with progressive prostate cancer and castrate levels of testosterone: +recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol +2008;26:1148-59. +59. +Rustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the +response to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst +2004;96:487-8. +60. +Vergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the +response to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup. +J Natl Cancer Inst 2000;92:1534-5. +61. +Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the +Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55. + +114 + + PrECOG Protocol Number: PrE0102 +Confidential +Date: 1/22/2014 + +20 Investigator’s Statement +1. + +I have carefully read this protocol entitled “Randomized, Double-Blind, +Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus +Everolimus in Post Menopausal Patients with Hormone-Receptor +Positive Metastatic Breast Center Resistant to Aromatase Inhibitor +Therapy, Version 2.0 dated 1/22/2014” (Protocol number PrE0102) +and agree that it contains all the necessary information required to +conduct the study. I agree to conduct the study as outlined in the protocol. + +2. + +I agree to conduct this study according to the moral, ethical and scientific +principles governing clinical research as set out in the Declaration of +Helsinki, the principles of GCP as described in 21 CFR and any applicable +local requirements. + +3. + +I understand that this trial and any subsequent changes to this trial will not +be initiated without approval of the appropriate Institutional Review Board, +and that all administrative requirements of the governing body of the +institution will be complied with fully. + +4. + +Informed written consent will be obtained from all participating patients in +accordance with institutional and FDA requirements as specified in Title +21, Code of Federal Regulations, Part 50. + +5. + +I understand that my signature on the Case Report Form indicates that I +have carefully reviewed each page and accept full responsibility for the +contents thereof. + +6. + +I understand that the information presented in this study protocol is +confidential, and I hereby assure that no information based on the conduct +of the study will be released without prior consent from PrECOG, LLC +unless this requirement is superseded by the Food and Drug +Administration. + +Principal Investigator: +PI Name: +Site Name: +Signature of PI: +Date of Signature: + +\ +MMM + +\ +DD + +115 + +YYYY + + \ No newline at end of file diff --git a/files/NCT01797120_sections.json b/files/NCT01797120_sections.json new file mode 100644 index 0000000..a73bc34 --- /dev/null +++ b/files/NCT01797120_sections.json @@ -0,0 +1,524 @@ +[ + { + "sectionNumber": "1", + "sectionTitle": "Introduction", + "text": "

See section 1 Introduction.

", + "parent": null + }, + { + "sectionNumber": "1.1", + "sectionTitle": "Background and Rationale", + "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor \u03b1 activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell\u2019s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole \u2265 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "parent": "1" + }, + { + "sectionNumber": "1.2", + "sectionTitle": "Breast Cancer", + "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "parent": "1" + }, + { + "sectionNumber": "1.3", + "sectionTitle": "Endocrine Therapy for Breast Cancer", + "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "parent": "1" + }, + { + "sectionNumber": "1.3.1", + "sectionTitle": "Fulvestrant for Post Menopausal Women with Breast Cancer", + "text": "
\n

Fulvestrant (Faslodex\u00ae, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex\u00ae\n(fulvestrant) Injection for \u201c\u2026the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy\u201d.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", + "parent": "1.3" + }, + { + "sectionNumber": "1.3.2", + "sectionTitle": "Fulvestrant for Aromatase Inhibitor (AI) Resistant Disease", + "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
", + "parent": "1.3" + }, + { + "sectionNumber": "1.3.3", + "sectionTitle": "Rationale for Fulvestrant for this Trial", + "text": "
\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", + "parent": "1.3" + }, + { + "sectionNumber": "1.4", + "sectionTitle": "Everolimus (RAD001)", + "text": "
\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican\u00ae) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress\u00ae) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor\u00ae and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor\u00ae received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia\u00ae in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor\u00ae was\napproved for \u201cprogressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease\u201d in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor\u00ae received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor\u00ae received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n\u2022

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

\u2022

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", + "parent": "1" + }, + { + "sectionNumber": "1.4.1", + "sectionTitle": "mTOR Pathway and Mechanism of Action", + "text": "
\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n\u2022\n\u2022\n\u2022

\n

\u2022\n\u2022

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n\u2022

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

\u2022

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 \u03bcM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or \u2018resistant\u2019 (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", + "parent": "1.4" + }, + { + "sectionNumber": "1.4.2", + "sectionTitle": "Pre-Clinical Safety", + "text": "
\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator\u2019s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-\u03c4 is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-\u03c4 and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator\u2019s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator\u2019s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican\u00ae, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress\u00ae) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator\u2019s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor\u00ae for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n\u2022\n\u2022\n\u2022\n\u2022

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor\u00ae) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence \u2265 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence \u2265\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence \u2265 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence \u2265 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator\u2019s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", + "parent": "1.4" + }, + { + "sectionNumber": "1.4.3", + "sectionTitle": "Clinical Experience", + "text": "

See section 1.4.3 Clinical Experience.

", + "parent": "1.4" + }, + { + "sectionNumber": "1.5", + "sectionTitle": "Rationale and Study Design", + "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "parent": "1" + }, + { + "sectionNumber": "2", + "sectionTitle": "Objectives", + "text": "

See section 2 Objectives.

", + "parent": null + }, + { + "sectionNumber": "2.1", + "sectionTitle": "Primary Objective", + "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "parent": "2" + }, + { + "sectionNumber": "2.2", + "sectionTitle": "Secondary Objectives", + "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "parent": "2" + }, + { + "sectionNumber": "3", + "sectionTitle": "Selection of Patients", + "text": "

See section 3 Selection of Patients.

", + "parent": null + }, + { + "sectionNumber": "3.1", + "sectionTitle": "Eligibility Criteria", + "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n\u2022\n\u2022

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n\u2022

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage \u2265 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

total white blood cell count (leukocytes, WBC) \u2265 3.0 x 109/L, absolute\nneutrophil count (ANC) \u2265 1.5 x 109/L and platelet count \u2265 100 x 109/L\nhemoglobin \u2265 9 g/dL\nserum bilirubin \u2264 1.5 x ULN\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\nserum creatinine \u2264 1.5 x ULN\nserum albumin \u2265 3 g/dL\nfasting serum cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND fasting\ntriglycerides \u2264 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR \u2264 1.5 (Anticoagulation is allowed if target INR \u2264 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin \u2264 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as \u2265 20 mm by chest x-ray, as \u2265\n10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n\u2022

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

\u2022

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

\u2022

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient\u2019s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "parent": "3" + }, + { + "sectionNumber": "4", + "sectionTitle": "Randomization Procedures", + "text": "

See section 4 Randomization Procedures.

", + "parent": null + }, + { + "sectionNumber": "4.1", + "sectionTitle": "Ethics", + "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "parent": "4" + }, + { + "sectionNumber": "4.2", + "sectionTitle": "Regulatory Requirements", + "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "parent": "4" + }, + { + "sectionNumber": "4.3", + "sectionTitle": "Patient Randomization", + "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin \u2264 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "parent": "4" + }, + { + "sectionNumber": "5", + "sectionTitle": "Treatment Plan", + "text": "

See section 5 Treatment Plan.

", + "parent": null + }, + { + "sectionNumber": "5.1", + "sectionTitle": "Administration Schedule", + "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "parent": "5" + }, + { + "sectionNumber": "5.2", + "sectionTitle": "Dosing and Administration", + "text": "

See section 5.2 Dosing and Administration.

", + "parent": "5" + }, + { + "sectionNumber": "5.2.1", + "sectionTitle": "Fulvestrant (Arm A and Arm B)", + "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "parent": "5.2" + }, + { + "sectionNumber": "5.2.2", + "sectionTitle": "Everolimus or Placebo (Arm A and Arm B)", + "text": "
\n

\u2022

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

\u2022

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

\u2022

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

\u2022

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

\u2022

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

\u2022

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

\u2022

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "parent": "5.2" + }, + { + "sectionNumber": "5.3", + "sectionTitle": "Dose Modifications and Toxicity Management", + "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", + "parent": "5" + }, + { + "sectionNumber": "5.3.1", + "sectionTitle": "Dose Modifications General Guidelines for Everolimus/Placebo", + "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n\u2022

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

\u2022

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is \u2264 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

\u2022

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

\u2022

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

\u2022

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

\u2022

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nIf resolution occurs within \u2264 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade \u2264 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, \u2265 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade \u22641

\n

(platelets <50, \u2265 25 x 10 /L)

\n

If resolution occurs \u2264 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, \u2265 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade \u2264 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade \u22641 or baseline\nvalue\nIf AE resolution occurs \u2264 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade \u2264 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade \u2264 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "parent": "5.3" + }, + { + "sectionNumber": "5.3.2", + "sectionTitle": "Common Adverse Events Associated with Everolimus", + "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for \u2265 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence \u2265 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence \u2265 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator\u2019s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

\u2264 baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n\u2264 baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n\u2022

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

\u2022

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered \u2018cured\u2019).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n\u02c32 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed \u201cmiracle mouth wash\u2019\u2019 QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using \u201cmiracle mouthwash\u2019\u2019.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and \u201cmiracle mouth wash\u201d.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and \u201cmiracle mouth wash\u201d\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase\u00ae) or Periogard\u00ae oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol\u2013containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to \u2264 grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade \u2264\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to \u2264 grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade \u2264 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to \u2264\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "parent": "5.3" + }, + { + "sectionNumber": "5.3.3", + "sectionTitle": "Concomitant Therapies", + "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken \u2264 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "parent": "5.3" + }, + { + "sectionNumber": "5.3.4", + "sectionTitle": "Prohibited Therapies and Restrictions", + "text": "
\n

The following restrictions apply during the entire duration of the study:\n\u2022

\n

No other investigational therapy should be given to patients.

\n

\u2022

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

\u2022

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

\u2022

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

\u2022

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

\u2022

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

\u2022

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

\u2022

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

\u2022

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

\u2022

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John\u2019s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week\u2019s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient\u2019s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "parent": "5.3" + }, + { + "sectionNumber": "5.3.5", + "sectionTitle": "Administration of Everolimus and CYP3A4 Inhibitors/Inducers", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "parent": "5.3" + }, + { + "sectionNumber": "5.4", + "sectionTitle": "Supportive Care", + "text": "

See section 5.4 Supportive Care.

", + "parent": "5" + }, + { + "sectionNumber": "5.5", + "sectionTitle": "Duration of Therapy", + "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to \u2264 grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "parent": "5" + }, + { + "sectionNumber": "5.6", + "sectionTitle": "Withdrawal of Patients from Study", + "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n\u2022

\n

Withdrawal of the patient\u2019s consent (patient\u2019s decision to withdraw for any reason)

\n

\u2022

\n

Termination of the study by PrECOG

\n

\u2022

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

\u2022

\n

Inability to comply with protocol

\n

\u2022

\n

Discretion of the investigator

\n

\u2022

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "parent": "5" + }, + { + "sectionNumber": "6", + "sectionTitle": "Measurement of Effect", + "text": "

See section 6 Measurement of Effect.

", + "parent": null + }, + { + "sectionNumber": "6.1", + "sectionTitle": "Antitumor Effect - Solid Tumors", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "parent": "6" + }, + { + "sectionNumber": "6.1.1", + "sectionTitle": "Definitions", + "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "parent": "6.1" + }, + { + "sectionNumber": "6.1.2", + "sectionTitle": "Disease Parameters", + "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n\u2022

\n

\u2265 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

\u2022

\n

\u2265 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

\u2022

\n

\u2265 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be \u2265 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with \u2265 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n\u2018Cystic lesions\u2019 thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "parent": "6.1" + }, + { + "sectionNumber": "6.1.3", + "sectionTitle": "Methods for Evaluation of Measurable Disease", + "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and \u2265 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n\u2022\n\u2022

\n

\u2022

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A \u2018positive\u2019 FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest \u201cincrease\u201d in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from \u201ctrace\u201d to\n\u201clarge\u201d, an increase in nodal disease from \u201clocalized\u201d to \u201cwidespread\u201d, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of \u201cnon-target\u201d lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient\u2019s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n\u201csymptomatic deterioration\u201d. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*\u2018Non-CR/Non-PD\u2019 is preferred over \u2018stable disease\u2019 for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "parent": "6.1" + }, + { + "sectionNumber": "6.1.4", + "sectionTitle": "Response Criteria", + "text": "

See section 6.1.4 Response Criteria.

", + "parent": "6.1" + }, + { + "sectionNumber": "6.1.5", + "sectionTitle": "Duration of Response", + "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "parent": "6.1" + }, + { + "sectionNumber": "6.1.6", + "sectionTitle": "Progression-Free Survival", + "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN \u2264 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

\u00a3

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

\u00a3

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: \u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: \u2264 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNAPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n\u00a3 Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "parent": "6.1" + }, + { + "sectionNumber": "7", + "sectionTitle": "Study Parameters", + "text": "

See section 7 Study Parameters.

", + "parent": null + }, + { + "sectionNumber": "7.1", + "sectionTitle": "Procedures by Visit", + "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "parent": "7" + }, + { + "sectionNumber": "7.1.1", + "sectionTitle": "Pre-Study", + "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin \u2264 4 weeks of randomization to protocol therapy:\n\u2022

\n

Medical history

\n

\u2022

\n

Assessment of baseline signs and symptoms

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

\u2022

\n

PT with INR

\n

\u2022

\n

Urinalysis

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n\u2022 known or suspected past hepatitis B infection\n\u2022 blood transfusion(s) prior to 1990\n\u2022 current or prior IV drug users\n\u2022 current or prior dialysis\n\u2022 household contact with hepatitis B infected patient(s)\n\u2022 current or prior high-risk sexual activity\n\u2022 body piercing or tattoos\n\u2022 mother known to have hepatitis B\n\u2022 history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon \u2018curative\u2019 treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "parent": "7.1" + }, + { + "sectionNumber": "7.1.2", + "sectionTitle": "Induction Phase", + "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within \u2264 7 days of Cycle 1 Day 1.

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

\u2022

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

\u2022

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "parent": "7.1" + }, + { + "sectionNumber": "7.1.3", + "sectionTitle": "End of Induction Phase / End of Treatment", + "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to \u2264 grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

\u2022

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "parent": "7.1" + }, + { + "sectionNumber": "7.1.4", + "sectionTitle": "Continuation Phase", + "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until \u2264 grade 1\nor if the grade is >1, the event must be permanent and stable.\n\u2022

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

\u2022

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n\u2022

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "parent": "7.1" + }, + { + "sectionNumber": "7.1.5", + "sectionTitle": "Follow-Up Off-Therapy", + "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264 grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "parent": "7.1" + }, + { + "sectionNumber": "8", + "sectionTitle": "Drug Formulation and Procurement", + "text": "

See section 8 Drug Formulation and Procurement.

", + "parent": null + }, + { + "sectionNumber": "8.1", + "sectionTitle": "Everolimus", + "text": "

See section 8.1 Everolimus.

", + "parent": "8" + }, + { + "sectionNumber": "8.1.1", + "sectionTitle": "Packaging and Labeling", + "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "parent": "8.1" + }, + { + "sectionNumber": "8.1.2", + "sectionTitle": "Storage Requirements/Stability", + "text": "
\n

Everolimus should be stored at room temperature between 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n\u2022

\n

Everolimus/placebo dose may be taken with or without food.

\n

\u2022

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

\u2022

\n

Vomited doses should not be replaced.

\n

\u2022

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "parent": "8.1" + }, + { + "sectionNumber": "8.1.3", + "sectionTitle": "Handling, Dispensing and Administration", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "parent": "8.1" + }, + { + "sectionNumber": "8.1.4", + "sectionTitle": "Side Effects", + "text": "
\n

The most common adverse reactions (incidence \u2265 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence \u2265 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", + "parent": "8.1" + }, + { + "sectionNumber": "8.1.5", + "sectionTitle": "Investigational Product Records at Investigational Site(s)", + "text": "
\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n\u2022

\n

Amount received and placed in storage area.

\n

\u2022

\n

Amount currently in storage area.

\n

\u2022

\n

Label ID number or batch number.

\n

\u2022

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

\u2022

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

\u2022

\n

Amount transferred to another area for dispensing or storage.

\n

\u2022

\n

Non-study disposition (e.g., wasted, broken).

\n

\u2022

\n

Amount returned to manufacturer, if applicable

\n

\u2022

\n

Amount destroyed at study site, if applicable

\n
", + "parent": "8.1" + }, + { + "sectionNumber": "8.1.6", + "sectionTitle": "Return and Destruction of Investigational Product", + "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site\u2019s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "parent": "8.1" + }, + { + "sectionNumber": "8.2", + "sectionTitle": "Fulvestrant", + "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide\u2122) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2\u00b0-8\u00b0C (36\u00b0-46\u00b0F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex\u00ae Package Insert 1621903 Rev 12/11)\n\u2022 Remove the glass syringe barrel from tray and check that it is not damaged\n\u2022 Remove perforated patient record label from syringe\n\u2022 Peel open the safety needle outer packaging.\n\u2022 Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n\u2022 Twist to lock the needle to the luer container.\n\u2022 Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n\u2022 Remove excess gas from the syringe.\n\u2022 Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle \u2018bevel up\u2019 position is\norientated to the lever arm (Figure 3).\n\u2022 Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n\u2022 Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n\u2022 If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n\u2022 Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex\u00ae treatment groups,\nregardless of the investigator\u2019s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex\u00ae and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex\u00ae If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher\u2019s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "parent": "8" + }, + { + "sectionNumber": "9", + "sectionTitle": "Statistical Considerations", + "text": "

See section 9 Statistical Considerations.

", + "parent": null + }, + { + "sectionNumber": "9.1", + "sectionTitle": "Primary Endpoint Analysis", + "text": "

See section 9.1 Primary Endpoint Analysis.

", + "parent": "9" + }, + { + "sectionNumber": "9.2", + "sectionTitle": "Safety Analyses", + "text": "
\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", + "parent": "9" + }, + { + "sectionNumber": "9.3", + "sectionTitle": "Analyses of Other Secondary Endpoints", + "text": "
\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
", + "parent": "9" + }, + { + "sectionNumber": "10", + "sectionTitle": "Adverse Event Reporting", + "text": "
\n

10 Adverse Event Reporting

\n
", + "parent": null + }, + { + "sectionNumber": "10.1", + "sectionTitle": "Collection of Safety Information", + "text": "
\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator\u2019s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n\u2022

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

\u2022

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

\u2022

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

\u2022

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

\u2022

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories \u2018Definite\u2019, \u2018probable\u2019 and \u2018possible\u2019 are considered study drug related.\nCategories \u2018not likely\u2019 and \u2018not related\u2019 are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
", + "parent": "10" + }, + { + "sectionNumber": "10.2", + "sectionTitle": "Handling of Serious Adverse Events (SAEs)", + "text": "
\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
", + "parent": "10" + }, + { + "sectionNumber": "10.2.1", + "sectionTitle": "SAE Definitions", + "text": "
\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n\u2022

\n

results in death,

\n

\u2022

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

\u2022

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

\u2022

\n

results in persistent or significant disability/incapacity,

\n

\u2022

\n

is a congenital anomaly/birth defect,

\n

\u2022

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
", + "parent": "10.2" + }, + { + "sectionNumber": "10.2.2", + "sectionTitle": "SAE Reporting Requirements", + "text": "
\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator\u2019s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM \u2013 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE\u2019s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "parent": "10.2" + }, + { + "sectionNumber": "10.3", + "sectionTitle": "Reporting of Second Primary Cancers", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", + "parent": "10" + }, + { + "sectionNumber": "11", + "sectionTitle": "Administrative", + "text": "
\n

11 Administrative

\n
", + "parent": null + }, + { + "sectionNumber": "11.1", + "sectionTitle": "Protocol Compliance", + "text": "
\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.2", + "sectionTitle": "Institutional Review Board", + "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.3", + "sectionTitle": "Informed Consent Procedures", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.4", + "sectionTitle": "Safety Communication", + "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.5", + "sectionTitle": "Monitoring", + "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.6", + "sectionTitle": "Study Records", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.7", + "sectionTitle": "Electronic Case Report Form (eCRF) Information", + "text": "
\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
", + "parent": "11" + }, + { + "sectionNumber": "11.8", + "sectionTitle": "Records Retention", + "text": "
\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n\u2022\n\u2022\n\u2022

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", + "parent": "11" + }, + { + "sectionNumber": "12", + "sectionTitle": "Glossary of Terms and List of Abbreviations", + "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n\u00b0C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

\u00b5M\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

\u00b5g

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", + "parent": null + }, + { + "sectionNumber": "13", + "sectionTitle": "Appendix A: Eligibility Checklist", + "text": "
\n

13 Appendix A: Eligibility Checklist\n\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n\u2264 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) \u2265 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) \u2265 1.5 x 10 /L and platelet count \u2265 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin \u2265 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin \u2264 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine \u2264 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin \u2265 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND Fasting Triglycerides \u2264 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR \u2264 1.5. (Anticoagulation is allowed if target INR \u2264 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n\u2265 20 mm by chest x-ray, as \u2265 10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n\u2022 Bisphosphonates, Zometa or Xgeva for bone metastases\n\u2022 Hormonal therapy (e.g., AI, Tamoxifen)\n\u2022 a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient\u2019s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", + "parent": null + }, + { + "sectionNumber": "14", + "sectionTitle": "Appendix B: ECOG Performance Status Scale", + "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "parent": null + }, + { + "sectionNumber": "15", + "sectionTitle": "Appendix C: Medications that can Inhibit/Induce CYP3A4 and PgP", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John\u2019s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John\u2019s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John\u2019s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA\u2019s\n\u201cGuidance for Industry, Drug Interaction Studies\u201d, the University of Washington\u2019s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", + "parent": null + }, + { + "sectionNumber": "16", + "sectionTitle": "Appendix D: New York Heart Association (NYHA) Cardiac Classification", + "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient\u2019s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
", + "parent": null + }, + { + "sectionNumber": "17", + "sectionTitle": "Appendix E: CTEP Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0", + "text": "
\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
", + "parent": null + }, + { + "sectionNumber": "18", + "sectionTitle": "Appendix F: Patient Pill Diary", + "text": "
\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
", + "parent": null + }, + { + "sectionNumber": "19", + "sectionTitle": "References", + "text": "
\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex\u00ae) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO\u2019Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses\u2019 Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator\u2019s Statement\n1.

\n

I have carefully read this protocol entitled \u201cRandomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014\u201d (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
", + "parent": null + }, + { + "sectionNumber": "20", + "sectionTitle": "Investigator's Statement", + "text": "

See section 20 Investigator's Statement.

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Protocol therapy must begin within 7 working days of randomization.", + "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). 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End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_3", + "extensionAttributes": [], + "name": "INDUCTION_PBO_FUL", + "label": "Induction: Fulvestrant + Placebo", + "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", + "transitionStartRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "Induction Phase Entry", + "label": "Induction Phase Entry", + "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Induction Phase Exit", + "label": "Induction Phase Exit", + "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_4" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_4", + "extensionAttributes": [], + "name": "CONTINUATION_EVE_FUL", + "label": "Continuation: Fulvestrant + Everolimus", + "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_5", + "extensionAttributes": [], + "name": "CONTINUATION_FUL", + "label": "Continuation: Fulvestrant alone", + "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_5" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_6", + "extensionAttributes": [], + "name": "FOLLOW_UP_ELEMENT", + "label": "Follow-Up Off-Therapy", + "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", + "transitionStartRule": { + "id": "TransitionRule_6", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Entry", + "label": "Follow-Up Off-Therapy Entry", + "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_7", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Exit", + "label": "Follow-Up Off-Therapy Exit", + "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + } + ], + "estimands": [ + { + "id": "Estimand_1", + "extensionAttributes": [], + "name": "Estimand for Progression-Free Survival (PFS)", + "label": "Primary Estimand", + "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", + "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_1", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_1", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_2", + "extensionAttributes": [], + "name": "Discontinuation of everolimus due to toxicity", + "label": "Discontinuation of everolimus due to toxicity", + "description": null, + "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", + "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_3", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", + "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_4", + "extensionAttributes": [], + "name": "Initiation of prohibited anti-cancer therapy before progression", + "label": "Initiation of prohibited anti-cancer therapy before progression", + "description": null, + "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", + "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_2", + "extensionAttributes": [], + "name": "Estimand for Overall Survival (OS)", + "label": "Secondary Estimand \u2014 OS", + "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_2", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_5", + "extensionAttributes": [], + "name": "Discontinuation of study treatment (any reason)", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", + "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_6", + "extensionAttributes": [], + "name": "Initiation of subsequent anti-cancer therapy after progression", + "label": "Initiation of subsequent anti-cancer therapy after progression", + "description": null, + "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", + "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_7", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", + "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_3", + "extensionAttributes": [], + "name": "Estimand for Time to Progression (TTP)", + "label": "Secondary Estimand \u2014 TTP", + "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_3", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_8", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_9", + "extensionAttributes": [], + "name": "Discontinuation of study treatment", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues study treatment before disease progression.", + "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_4", + "extensionAttributes": [], + "name": "Estimand for Objective Response Rate (ORR)", + "label": "Secondary Estimand \u2014 ORR", + "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", + "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_4", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_10", + "extensionAttributes": [], + "name": "Death or progression before first response assessment", + "label": "Death or progression before first response assessment", + "description": null, + "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", + "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_11", + "extensionAttributes": [], + "name": "Treatment discontinuation before response assessment", + "label": "Treatment discontinuation before response assessment", + "description": null, + "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", + "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_5", + "extensionAttributes": [], + "name": "Estimand for Clinical Benefit Rate (CBR)", + "label": "Secondary Estimand \u2014 CBR", + "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", + "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_5", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_12", + "extensionAttributes": [], + "name": "Death or progression before 6-month stable disease threshold", + "label": "Death or progression before 6-month stable disease threshold", + "description": null, + "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", + "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_13", + "extensionAttributes": [], + "name": "Treatment discontinuation before 6-month landmark", + "label": "Treatment discontinuation before 6-month landmark", + "description": null, + "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", + "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_6", + "extensionAttributes": [], + "name": "Estimand for Safety and Tolerability", + "label": "Secondary Estimand \u2014 Safety", + "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", + "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_6", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_14", + "extensionAttributes": [], + "name": "Treatment discontinuation", + "label": "Treatment discontinuation", + "description": null, + "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", + "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_15", + "extensionAttributes": [], + "name": "Dose reduction or interruption of everolimus", + "label": "Dose reduction or interruption of everolimus", + "description": null, + "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", + "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + } + ], + "indications": [ + { + "id": "Indication_1", + "extensionAttributes": [], + "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "label": "HR+ AI-Resistant Metastatic Breast Cancer", + "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", + "isRareDisease": false, + "codes": [ + { + "id": "Code_7947", + "extensionAttributes": [], + "code": "C9246", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Hormone Receptor-Positive Breast Carcinoma", + "instanceType": "Code" + }, + { + "id": "Code_7948", + "extensionAttributes": [], + "code": "C7771", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Metastatic Breast Carcinoma", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + } + ], + "studyInterventionIds": [ + "StudyIntervention_3", + "StudyIntervention_4", + "StudyIntervention_5" + ], + "objectives": [ + { + "id": "Objective_1", + "extensionAttributes": [], + "name": "Primary Objective", + "label": "Primary Objective", + "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2355", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_1", + "extensionAttributes": [], + "name": "Progression-Free Survival (PFS)", + "label": "Progression-Free Survival (PFS)", + "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", + "level": { + "id": "Code_2356", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_2", + "extensionAttributes": [], + "name": "Secondary Objective", + "label": "Secondary Objective", + "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2357", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_2", + "extensionAttributes": [], + "name": "Overall Survival (OS)", + "label": "Overall Survival (OS)", + "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize overall survival in the two treatment arms.", + "level": { + "id": "Code_2358", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_3", + "extensionAttributes": [], + "name": "Time to Progression (TTP)", + "label": "Time to Progression (TTP)", + "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To estimate and compare median time to disease progression between treatment arms.", + "level": { + "id": "Code_2359", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_4", + "extensionAttributes": [], + "name": "Objective Response Rate (ORR)", + "label": "Objective Response Rate (ORR)", + "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", + "level": { + "id": "Code_2360", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_5", + "extensionAttributes": [], + "name": "Clinical Benefit Rate (CBR)", + "label": "Clinical Benefit Rate (CBR)", + "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", + "level": { + "id": "Code_2361", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_6", + "extensionAttributes": [], + "name": "Safety and Tolerability", + "label": "Safety and Tolerability", + "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", + "level": { + "id": "Code_2362", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + } + ], + "population": { + "id": "StudyDesignPopulation_1", + "extensionAttributes": [], + "name": "Population_1", + "label": null, + "description": null, + "includesHealthySubjects": false, + "plannedEnrollmentNumber": null, + "plannedCompletionNumber": null, + "plannedSex": [], + "criterionIds": [], + "plannedAge": null, + "notes": [], + "cohorts": [], + "instanceType": "StudyDesignPopulation" + }, + "scheduleTimelines": [ + { + "id": "ScheduleTimeline_1", + "extensionAttributes": [], + "name": "MAIN_TIMELINE", + "label": "PrE0102 Main Schedule of Activities Timeline", + "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", + "mainTimeline": true, + "entryCondition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", + "entryId": "ScheduledActivityInstance_1", + "exits": [], + "timings": [ + { + "id": "Timing_1", + "extensionAttributes": [], + "name": "C1D1_ANCHOR", + "label": "Cycle 1 Day 1 (anchor)", + "description": "Cycle 1 Day 1 (anchor)", + "type": { + "id": "Code_10080", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P0D", + "valueLabel": "Day 1", + "relativeToFrom": { + "id": "Code_10081", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_2", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_2", + "extensionAttributes": [], + "name": "SCREEN_WINDOW", + "label": "Within 4 weeks before C1D1", + "description": "Within 4 weeks before C1D1", + "type": { + "id": "Code_10082", + "extensionAttributes": [], + "code": "C201357", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Before", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "Up to 28 days before", + "relativeToFrom": { + "id": "Code_10083", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_1", + "windowLower": "P0D", + "windowUpper": "P28D", + "windowLabel": "<= 4 weeks before C1D1", + "instanceType": "Timing" + }, + { + "id": "Timing_3", + "extensionAttributes": [], + "name": "C1D15_OFFSET", + "label": "14 days after C1D1", + "description": "14 days after C1D1", + "type": { + "id": "Code_10084", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P14D", + "valueLabel": "Day 15", + "relativeToFrom": { + "id": "Code_10085", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_4", + "extensionAttributes": [], + "name": "C2D1_OFFSET", + "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "type": { + "id": "Code_10086", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10087", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_4", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_5", + "extensionAttributes": [], + "name": "C3D1_OFFSET", + "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "type": { + "id": "Code_10088", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10089", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_5", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_6", + "extensionAttributes": [], + "name": "C4D1_OFFSET", + "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "type": { + "id": "Code_10090", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10091", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_6", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_7", + "extensionAttributes": [], + "name": "C5D1_OFFSET", + "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "type": { + "id": "Code_10092", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10093", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_8", + "extensionAttributes": [], + "name": "C6D1_OFFSET", + "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10094", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_8", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_9", + "extensionAttributes": [], + "name": "C7D1_OFFSET", + "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10095", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_9", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_10", + "extensionAttributes": [], + "name": "C8D1_OFFSET", + "label": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "description": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "type": { + "id": "Code_10096", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10097", + "extensionAttributes": [], + "code": "C201355", + 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See section 1 Introduction.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_2", + "extensionAttributes": [], + "name": "NCI_1_1", + "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor α activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell’s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole ≥ 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_3", + "extensionAttributes": [], + "name": "NCI_1_2", + "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_4", + "extensionAttributes": [], + "name": "NCI_1_3", + "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_5", + "extensionAttributes": [], + "name": "NCI_1_3_1", + "text": "
\n

Fulvestrant (Faslodex®, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex®\n(fulvestrant) Injection for “…the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy”.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
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\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
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\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_8", + "extensionAttributes": [], + "name": "NCI_1_4", + "text": "
\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican®) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress®) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor® and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor® received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia® in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor® was\napproved for “progressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease” in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor® received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor® received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n•

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

•

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_9", + "extensionAttributes": [], + "name": "NCI_1_4_1", + "text": "
\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n•\n•\n•

\n

•\n•

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n•

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

•

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 μM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or ‘resistant’ (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_10", + "extensionAttributes": [], + "name": "NCI_1_4_2", + "text": "
\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator’s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-τ is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-τ and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator’s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator’s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican®, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress®) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator’s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor® for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n•\n•\n•\n•

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor®) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence ≥ 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence ≥\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence ≥ 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator’s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_11", + "extensionAttributes": [], + "name": "NCI_1_4_3", + "text": "

See section 1.4.3 Clinical Experience.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_12", + "extensionAttributes": [], + "name": "NCI_1_5", + "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_13", + "extensionAttributes": [], + "name": "NCI_2", + "text": "

See section 2 Objectives.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_14", + "extensionAttributes": [], + "name": "NCI_2_1", + "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_15", + "extensionAttributes": [], + "name": "NCI_2_2", + "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_16", + "extensionAttributes": [], + "name": "NCI_3", + "text": "

See section 3 Selection of Patients.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_17", + "extensionAttributes": [], + "name": "NCI_3_1", + "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n•\n•

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n•

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n•\n•\n•\n•

\n

•

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage ≥ 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n•\n•\n•\n•\n•\n•\n•

\n

•

\n

total white blood cell count (leukocytes, WBC) ≥ 3.0 x 109/L, absolute\nneutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L\nhemoglobin ≥ 9 g/dL\nserum bilirubin ≤ 1.5 x ULN\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\nserum creatinine ≤ 1.5 x ULN\nserum albumin ≥ 3 g/dL\nfasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting\ntriglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR ≤ 1.5 (Anticoagulation is allowed if target INR ≤ 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin ≤ 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as ≥ 20 mm by chest x-ray, as ≥\n10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n•

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

•

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

•

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient’s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_18", + "extensionAttributes": [], + "name": "NCI_4", + "text": "

See section 4 Randomization Procedures.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_19", + "extensionAttributes": [], + "name": "NCI_4_1", + "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_20", + "extensionAttributes": [], + "name": "NCI_4_2", + "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_21", + "extensionAttributes": [], + "name": "NCI_4_3", + "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin ≤ 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_22", + "extensionAttributes": [], + "name": "NCI_5", + "text": "

See section 5 Treatment Plan.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_23", + "extensionAttributes": [], + "name": "NCI_5_1", + "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_24", + "extensionAttributes": [], + "name": "NCI_5_2", + "text": "

See section 5.2 Dosing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_25", + "extensionAttributes": [], + "name": "NCI_5_2_1", + "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_26", + "extensionAttributes": [], + "name": "NCI_5_2_2", + "text": "
\n

•

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

•

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

•

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

•

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

•

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

•

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

•

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_27", + "extensionAttributes": [], + "name": "NCI_5_3", + "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_28", + "extensionAttributes": [], + "name": "NCI_5_3_1", + "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n•

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

•

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is ≤ 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

•

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

•

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

•

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

•

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nIf resolution occurs within ≤ 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade ≤ 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, ≥ 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade ≤1

\n

(platelets <50, ≥ 25 x 10 /L)

\n

If resolution occurs ≤ 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, ≥ 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade ≤ 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade ≤1 or baseline\nvalue\nIf AE resolution occurs ≤ 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade ≤ 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade ≤ 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_29", + "extensionAttributes": [], + "name": "NCI_5_3_2", + "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for ≥ 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence ≥ 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence ≥ 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator’s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

≤ baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n≤ baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n•

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

•

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered ‘cured’).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n˃2 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed “miracle mouth wash’’ QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using “miracle mouthwash’’.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and “miracle mouth wash”.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and “miracle mouth wash”\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase®) or Periogard® oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol–containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to ≤ grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade ≤\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to ≤ grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade ≤ 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to ≤\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_30", + "extensionAttributes": [], + "name": "NCI_5_3_3", + "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken ≤ 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_31", + "extensionAttributes": [], + "name": "NCI_5_3_4", + "text": "
\n

The following restrictions apply during the entire duration of the study:\n•

\n

No other investigational therapy should be given to patients.

\n

•

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

•

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

•

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

•

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

•

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

•

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

•

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

•

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

•

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John’s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week’s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient’s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_32", + "extensionAttributes": [], + "name": "NCI_5_3_5", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_33", + "extensionAttributes": [], + "name": "NCI_5_4", + "text": "

See section 5.4 Supportive Care.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_34", + "extensionAttributes": [], + "name": "NCI_5_5", + "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to ≤ grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_35", + "extensionAttributes": [], + "name": "NCI_5_6", + "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n•

\n

Withdrawal of the patient’s consent (patient’s decision to withdraw for any reason)

\n

•

\n

Termination of the study by PrECOG

\n

•

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

•

\n

Inability to comply with protocol

\n

•

\n

Discretion of the investigator

\n

•

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_36", + "extensionAttributes": [], + "name": "NCI_6", + "text": "

See section 6 Measurement of Effect.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_37", + "extensionAttributes": [], + "name": "NCI_6_1", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_38", + "extensionAttributes": [], + "name": "NCI_6_1_1", + "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_39", + "extensionAttributes": [], + "name": "NCI_6_1_2", + "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n•

\n

≥ 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

•

\n

≥ 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

•

\n

≥ 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be ≥ 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with ≥ 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n‘Cystic lesions’ thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_40", + "extensionAttributes": [], + "name": "NCI_6_1_3", + "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and ≥ 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n•\n•

\n

•

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest “increase” in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from “trace” to\n“large”, an increase in nodal disease from “localized” to “widespread”, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of “non-target” lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient’s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n“symptomatic deterioration”. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*‘Non-CR/Non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_41", + "extensionAttributes": [], + "name": "NCI_6_1_4", + "text": "

See section 6.1.4 Response Criteria.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_42", + "extensionAttributes": [], + "name": "NCI_6_1_5", + "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_43", + "extensionAttributes": [], + "name": "NCI_6_1_6", + "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

£

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

£

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: ≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: ≤ 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNAPCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n£ Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_44", + "extensionAttributes": [], + "name": "NCI_7", + "text": "

See section 7 Study Parameters.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_45", + "extensionAttributes": [], + "name": "NCI_7_1", + "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_46", + "extensionAttributes": [], + "name": "NCI_7_1_1", + "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin ≤ 4 weeks of randomization to protocol therapy:\n•

\n

Medical history

\n

•

\n

Assessment of baseline signs and symptoms

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

•

\n

PT with INR

\n

•

\n

Urinalysis

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n• known or suspected past hepatitis B infection\n• blood transfusion(s) prior to 1990\n• current or prior IV drug users\n• current or prior dialysis\n• household contact with hepatitis B infected patient(s)\n• current or prior high-risk sexual activity\n• body piercing or tattoos\n• mother known to have hepatitis B\n• history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon ‘curative’ treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_47", + "extensionAttributes": [], + "name": "NCI_7_1_2", + "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within ≤ 7 days of Cycle 1 Day 1.

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

•

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

•

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_48", + "extensionAttributes": [], + "name": "NCI_7_1_3", + "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to ≤ grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

•

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_49", + "extensionAttributes": [], + "name": "NCI_7_1_4", + "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until ≤ grade 1\nor if the grade is >1, the event must be permanent and stable.\n•

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

•

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

•

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n•

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_50", + "extensionAttributes": [], + "name": "NCI_7_1_5", + "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until ≤ grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_51", + "extensionAttributes": [], + "name": "NCI_8", + "text": "

See section 8 Drug Formulation and Procurement.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_52", + "extensionAttributes": [], + "name": "NCI_8_1", + "text": "

See section 8.1 Everolimus.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_53", + "extensionAttributes": [], + "name": "NCI_8_1_1", + "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_54", + "extensionAttributes": [], + "name": "NCI_8_1_2", + "text": "
\n

Everolimus should be stored at room temperature between 20°C to 25°C (68°F to 77°F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n•

\n

Everolimus/placebo dose may be taken with or without food.

\n

•

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

•

\n

Vomited doses should not be replaced.

\n

•

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n•\n•\n•\n•\n•

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_55", + "extensionAttributes": [], + "name": "NCI_8_1_3", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_56", + "extensionAttributes": [], + "name": "NCI_8_1_4", + "text": "
\n

The most common adverse reactions (incidence ≥ 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence ≥ 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_57", + "extensionAttributes": [], + "name": "NCI_8_1_5", + "text": "
\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n•

\n

Amount received and placed in storage area.

\n

•

\n

Amount currently in storage area.

\n

•

\n

Label ID number or batch number.

\n

•

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

•

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

•

\n

Amount transferred to another area for dispensing or storage.

\n

•

\n

Non-study disposition (e.g., wasted, broken).

\n

•

\n

Amount returned to manufacturer, if applicable

\n

•

\n

Amount destroyed at study site, if applicable

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_58", + "extensionAttributes": [], + "name": "NCI_8_1_6", + "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site’s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_59", + "extensionAttributes": [], + "name": "NCI_8_2", + "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide™) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2°-8°C (36°-46°F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex® Package Insert 1621903 Rev 12/11)\n• Remove the glass syringe barrel from tray and check that it is not damaged\n• Remove perforated patient record label from syringe\n• Peel open the safety needle outer packaging.\n• Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n• Twist to lock the needle to the luer container.\n• Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n• Remove excess gas from the syringe.\n• Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle ‘bevel up’ position is\norientated to the lever arm (Figure 3).\n• Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n• Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n• If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n• Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex® treatment groups,\nregardless of the investigator’s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex® and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex® If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher’s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_60", + "extensionAttributes": [], + "name": "NCI_9", + "text": "

See section 9 Statistical Considerations.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_61", + "extensionAttributes": [], + "name": "NCI_9_1", + "text": "

See section 9.1 Primary Endpoint Analysis.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_62", + "extensionAttributes": [], + "name": "NCI_9_2", + "text": "
\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_63", + "extensionAttributes": [], + "name": "NCI_9_3", + "text": "
\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_64", + "extensionAttributes": [], + "name": "NCI_10", + "text": "
\n

10 Adverse Event Reporting

\n
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\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator’s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n•

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

•

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

•

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

•

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

•

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories ‘Definite’, ‘probable’ and ‘possible’ are considered study drug related.\nCategories ‘not likely’ and ‘not related’ are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until ≤\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_66", + "extensionAttributes": [], + "name": "NCI_10_2", + "text": "
\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_67", + "extensionAttributes": [], + "name": "NCI_10_2_1", + "text": "
\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n•

\n

results in death,

\n

•

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

•

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

•

\n

results in persistent or significant disability/incapacity,

\n

•

\n

is a congenital anomaly/birth defect,

\n

•

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_68", + "extensionAttributes": [], + "name": "NCI_10_2_2", + "text": "
\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator’s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM – 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE’s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_69", + "extensionAttributes": [], + "name": "NCI_10_3", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_70", + "extensionAttributes": [], + "name": "NCI_11", + "text": "
\n

11 Administrative

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_71", + "extensionAttributes": [], + "name": "NCI_11_1", + "text": "
\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_72", + "extensionAttributes": [], + "name": "NCI_11_2", + "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_73", + "extensionAttributes": [], + "name": "NCI_11_3", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
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\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_75", + "extensionAttributes": [], + "name": "NCI_11_5", + "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_76", + "extensionAttributes": [], + "name": "NCI_11_6", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_77", + "extensionAttributes": [], + "name": "NCI_11_7", + "text": "
\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
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\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n•\n•\n•

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
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\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n°C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

µM\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

µg

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_80", + "extensionAttributes": [], + "name": "NCI_13", + "text": "
\n

13 Appendix A: Eligibility Checklist\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n≤ 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) ≥ 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) ≥ 1.5 x 10 /L and platelet count ≥ 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin ≥ 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin ≤ 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine ≤ 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin ≥ 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND Fasting Triglycerides ≤ 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR ≤ 1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n≥ 20 mm by chest x-ray, as ≥ 10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n• Bisphosphonates, Zometa or Xgeva for bone metastases\n• Hormonal therapy (e.g., AI, Tamoxifen)\n• a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient’s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_81", + "extensionAttributes": [], + "name": "NCI_14", + "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_82", + "extensionAttributes": [], + "name": "NCI_15", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John’s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John’s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John’s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA’s\n“Guidance for Industry, Drug Interaction Studies”, the University of Washington’s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_83", + "extensionAttributes": [], + "name": "NCI_16", + "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient’s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_84", + "extensionAttributes": [], + "name": "NCI_17", + "text": "
\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_85", + "extensionAttributes": [], + "name": "NCI_18", + "text": "
\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
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\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

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17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex®) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

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30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO’Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

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45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses’ Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

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58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator’s Statement\n1.

\n

I have carefully read this protocol entitled “Randomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014” (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
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"code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C67365", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_288", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_289", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": 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"decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_293", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_294", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_295", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_296", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_297", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_298", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_299", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": 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"http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_307", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.5183f82c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_308", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_309", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_317", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_318", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_319", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": false, + "coding": [ + { + "code": "C83219", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": 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"http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": 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"C49691", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b6e07c4c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_337", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_338", + "name": "TSVALCD", + "label": "TSVALCD", + "mandatory": false, + "coding": [ + { + "code": "C117458", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_339", + "name": "TSVCDREF", + "label": "TSVCDREF", + "mandatory": false, + "coding": [ + { + "code": "C117460", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + 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"http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_307", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.5183f82c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_308", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_309", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"decode": "Concomitant Medication Class" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "CMINDC", + "label": "CMINDC", + "mandatory": false, + "coding": [ + { + "code": "C83085", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "CMDOSE", + "label": "CMDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": 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"http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": 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"decode": "Trial Summary Parameter Name of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_340", + "name": "TSVCDVER", + "label": "TSVCDVER", + "mandatory": false, + "coding": [ + { + "code": "C117461", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_341", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_342", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.3705a725" + }, + { 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"decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_350", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_351", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C42574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Time" + } + ], + "codeList": "CL.3705a725" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_352", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_353", + 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Time" + } + ] + } + ] +} diff --git a/output/json/NCT01797120-latest.json b/output/json/NCT01797120-latest.json new file mode 100644 index 0000000..ac0703c --- /dev/null +++ b/output/json/NCT01797120-latest.json @@ -0,0 +1,14385 @@ +{ + "study": { + "id": "Study_60", + "extensionAttributes": [], + "name": "NCT01797120", + "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. 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Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", + "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", + "versions": [ + { + "id": "StudyVersion_1", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_44", + "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", + "valueExtensionClass": { + "id": "ExtensionClass_1", + "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_45", + "url": "tool-name", + "valueString": "SoA Workbench", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_46", + "url": "tool-version", + "valueString": "pi-fix-bc-props-specs-in-usdm", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_47", + "url": "usdm-creation-date", + "valueString": "20260716T11:34", + "instanceType": "ExtensionAttribute" + } + ], + "instanceType": "ExtensionClass" + }, + "instanceType": "ExtensionAttribute" + } + ], + "versionIdentifier": "1", + "rationale": "", + "studyIdentifiers": [ + { + "id": "StudyIdentifier_1", + "extensionAttributes": [], + "text": "PrE0102", + "scopeId": "Organization_1", + "instanceType": "StudyIdentifier" + } + ], + "referenceIdentifiers": [], + "studyDesigns": [ + { + "id": "InterventionalStudyDesign_1", + "extensionAttributes": [], + "name": "PrE0102", + "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", + "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. 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Protocol therapy must begin within 7 working days of randomization.", + "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "notes": [], + "instanceType": "Encounter" + }, + { + "id": "Encounter_2", + "extensionAttributes": [], + "name": "C1D1", + "label": "Cycle 1 Day 1", + "description": "First day fulvestrant is given with everolimus/placebo; start of Induction Phase. 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Protocol therapy must begin within 7 working days of randomization.", + "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). 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End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_3", + "extensionAttributes": [], + "name": "INDUCTION_PBO_FUL", + "label": "Induction: Fulvestrant + Placebo", + "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", + "transitionStartRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "Induction Phase Entry", + "label": "Induction Phase Entry", + "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Induction Phase Exit", + "label": "Induction Phase Exit", + "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_4" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_4", + "extensionAttributes": [], + "name": "CONTINUATION_EVE_FUL", + "label": "Continuation: Fulvestrant + Everolimus", + "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_5", + "extensionAttributes": [], + "name": "CONTINUATION_FUL", + "label": "Continuation: Fulvestrant alone", + "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_5" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_6", + "extensionAttributes": [], + "name": "FOLLOW_UP_ELEMENT", + "label": "Follow-Up Off-Therapy", + "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", + "transitionStartRule": { + "id": "TransitionRule_6", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Entry", + "label": "Follow-Up Off-Therapy Entry", + "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_7", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Exit", + "label": "Follow-Up Off-Therapy Exit", + "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + } + ], + "estimands": [ + { + "id": "Estimand_1", + "extensionAttributes": [], + "name": "Estimand for Progression-Free Survival (PFS)", + "label": "Primary Estimand", + "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. 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The time-to-event variable captures whichever occurs first: progression or death.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_2", + "extensionAttributes": [], + "name": "Discontinuation of everolimus due to toxicity", + "label": "Discontinuation of everolimus due to toxicity", + "description": null, + "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", + "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_3", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", + "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_4", + "extensionAttributes": [], + "name": "Initiation of prohibited anti-cancer therapy before progression", + "label": "Initiation of prohibited anti-cancer therapy before progression", + "description": null, + "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", + "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_2", + "extensionAttributes": [], + "name": "Estimand for Overall Survival (OS)", + "label": "Secondary Estimand \u2014 OS", + "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_2", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_5", + "extensionAttributes": [], + "name": "Discontinuation of study treatment (any reason)", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", + "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_6", + "extensionAttributes": [], + "name": "Initiation of subsequent anti-cancer therapy after progression", + "label": "Initiation of subsequent anti-cancer therapy after progression", + "description": null, + "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", + "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_7", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", + "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_3", + "extensionAttributes": [], + "name": "Estimand for Time to Progression (TTP)", + "label": "Secondary Estimand \u2014 TTP", + "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_3", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_8", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_9", + "extensionAttributes": [], + "name": "Discontinuation of study treatment", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues study treatment before disease progression.", + "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_4", + "extensionAttributes": [], + "name": "Estimand for Objective Response Rate (ORR)", + "label": "Secondary Estimand \u2014 ORR", + "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", + "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_4", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_10", + "extensionAttributes": [], + "name": "Death or progression before first response assessment", + "label": "Death or progression before first response assessment", + "description": null, + "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", + "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_11", + "extensionAttributes": [], + "name": "Treatment discontinuation before response assessment", + "label": "Treatment discontinuation before response assessment", + "description": null, + "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", + "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_5", + "extensionAttributes": [], + "name": "Estimand for Clinical Benefit Rate (CBR)", + "label": "Secondary Estimand \u2014 CBR", + "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", + "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_5", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_12", + "extensionAttributes": [], + "name": "Death or progression before 6-month stable disease threshold", + "label": "Death or progression before 6-month stable disease threshold", + "description": null, + "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", + "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_13", + "extensionAttributes": [], + "name": "Treatment discontinuation before 6-month landmark", + "label": "Treatment discontinuation before 6-month landmark", + "description": null, + "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", + "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_6", + "extensionAttributes": [], + "name": "Estimand for Safety and Tolerability", + "label": "Secondary Estimand \u2014 Safety", + "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", + "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_6", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_14", + "extensionAttributes": [], + "name": "Treatment discontinuation", + "label": "Treatment discontinuation", + "description": null, + "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", + "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_15", + "extensionAttributes": [], + "name": "Dose reduction or interruption of everolimus", + "label": "Dose reduction or interruption of everolimus", + "description": null, + "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", + "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + } + ], + "indications": [ + { + "id": "Indication_1", + "extensionAttributes": [], + "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "label": "HR+ AI-Resistant Metastatic Breast Cancer", + "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", + "isRareDisease": false, + "codes": [ + { + "id": "Code_7947", + "extensionAttributes": [], + "code": "C9246", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Hormone Receptor-Positive Breast Carcinoma", + "instanceType": "Code" + }, + { + "id": "Code_7948", + "extensionAttributes": [], + "code": "C7771", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Metastatic Breast Carcinoma", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + } + ], + "studyInterventionIds": [ + "StudyIntervention_3", + "StudyIntervention_4", + "StudyIntervention_5" + ], + "objectives": [ + { + "id": "Objective_1", + "extensionAttributes": [], + "name": "Primary Objective", + "label": "Primary Objective", + "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2355", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_1", + "extensionAttributes": [], + "name": "Progression-Free Survival (PFS)", + "label": "Progression-Free Survival (PFS)", + "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", + "level": { + "id": "Code_2356", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_2", + "extensionAttributes": [], + "name": "Secondary Objective", + "label": "Secondary Objective", + "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2357", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_2", + "extensionAttributes": [], + "name": "Overall Survival (OS)", + "label": "Overall Survival (OS)", + "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize overall survival in the two treatment arms.", + "level": { + "id": "Code_2358", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_3", + "extensionAttributes": [], + "name": "Time to Progression (TTP)", + "label": "Time to Progression (TTP)", + "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To estimate and compare median time to disease progression between treatment arms.", + "level": { + "id": "Code_2359", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_4", + "extensionAttributes": [], + "name": "Objective Response Rate (ORR)", + "label": "Objective Response Rate (ORR)", + "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", + "level": { + "id": "Code_2360", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_5", + "extensionAttributes": [], + "name": "Clinical Benefit Rate (CBR)", + "label": "Clinical Benefit Rate (CBR)", + "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", + "level": { + "id": "Code_2361", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_6", + "extensionAttributes": [], + "name": "Safety and Tolerability", + "label": "Safety and Tolerability", + "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", + "level": { + "id": "Code_2362", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + } + ], + "population": { + "id": "StudyDesignPopulation_1", + "extensionAttributes": [], + "name": "Population_1", + "label": null, + "description": null, + "includesHealthySubjects": false, + "plannedEnrollmentNumber": null, + "plannedCompletionNumber": null, + "plannedSex": [], + "criterionIds": [], + "plannedAge": null, + "notes": [], + "cohorts": [], + "instanceType": "StudyDesignPopulation" + }, + "scheduleTimelines": [ + { + "id": "ScheduleTimeline_1", + "extensionAttributes": [], + "name": "MAIN_TIMELINE", + "label": "PrE0102 Main Schedule of Activities Timeline", + "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", + "mainTimeline": true, + "entryCondition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", + "entryId": "ScheduledActivityInstance_1", + "exits": [], + "timings": [ + { + "id": "Timing_1", + "extensionAttributes": [], + "name": "C1D1_ANCHOR", + "label": "Cycle 1 Day 1 (anchor)", + "description": "Cycle 1 Day 1 (anchor)", + "type": { + "id": "Code_10080", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P0D", + "valueLabel": "Day 1", + "relativeToFrom": { + "id": "Code_10081", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_2", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_2", + "extensionAttributes": [], + "name": "SCREEN_WINDOW", + "label": "Within 4 weeks before C1D1", + "description": "Within 4 weeks before C1D1", + "type": { + "id": "Code_10082", + "extensionAttributes": [], + "code": "C201357", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Before", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "Up to 28 days before", + "relativeToFrom": { + "id": "Code_10083", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_1", + "windowLower": "P0D", + "windowUpper": "P28D", + "windowLabel": "<= 4 weeks before C1D1", + "instanceType": "Timing" + }, + { + "id": "Timing_3", + "extensionAttributes": [], + "name": "C1D15_OFFSET", + "label": "14 days after C1D1", + "description": "14 days after C1D1", + "type": { + "id": "Code_10084", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P14D", + "valueLabel": "Day 15", + "relativeToFrom": { + "id": "Code_10085", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_4", + "extensionAttributes": [], + "name": "C2D1_OFFSET", + "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "type": { + "id": "Code_10086", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10087", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_4", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_5", + "extensionAttributes": [], + "name": "C3D1_OFFSET", + "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "type": { + "id": "Code_10088", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10089", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_5", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_6", + "extensionAttributes": [], + "name": "C4D1_OFFSET", + "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "type": { + "id": "Code_10090", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10091", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_6", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_7", + "extensionAttributes": [], + "name": "C5D1_OFFSET", + "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "type": { + "id": "Code_10092", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10093", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_8", + "extensionAttributes": [], + "name": "C6D1_OFFSET", + "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10094", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_8", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_9", + "extensionAttributes": [], + "name": "C7D1_OFFSET", + "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10095", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_9", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_10", + "extensionAttributes": [], + "name": "C8D1_OFFSET", + "label": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "description": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "type": { + "id": "Code_10096", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10097", + "extensionAttributes": [], + "code": "C201355", + 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See section 1 Introduction.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_2", + "extensionAttributes": [], + "name": "NCI_1_1", + "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor \u03b1 activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell\u2019s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole \u2265 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_3", + "extensionAttributes": [], + "name": "NCI_1_2", + "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_4", + "extensionAttributes": [], + "name": "NCI_1_3", + "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_5", + "extensionAttributes": [], + "name": "NCI_1_3_1", + "text": "
\n

Fulvestrant (Faslodex\u00ae, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex\u00ae\n(fulvestrant) Injection for \u201c\u2026the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy\u201d.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_6", + "extensionAttributes": [], + "name": "NCI_1_3_2", + "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

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Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

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\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican\u00ae) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress\u00ae) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor\u00ae and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor\u00ae received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia\u00ae in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor\u00ae was\napproved for \u201cprogressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease\u201d in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor\u00ae received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor\u00ae received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n\u2022

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

\u2022

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

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At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

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targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n\u2022\n\u2022\n\u2022

\n

\u2022\n\u2022

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

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inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

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Preclinical Studies

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Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n\u2022

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

\u2022

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 \u03bcM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or \u2018resistant\u2019 (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

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In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator\u2019s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-\u03c4 is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-\u03c4 and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator\u2019s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator\u2019s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican\u00ae, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress\u00ae) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator\u2019s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor\u00ae for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n\u2022\n\u2022\n\u2022\n\u2022

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor\u00ae) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence \u2265 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence \u2265\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence \u2265 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence \u2265 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator\u2019s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

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See section 1.4.3 Clinical Experience.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_12", + "extensionAttributes": [], + "name": "NCI_1_5", + "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_13", + "extensionAttributes": [], + "name": "NCI_2", + "text": "

See section 2 Objectives.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_14", + "extensionAttributes": [], + "name": "NCI_2_1", + "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_15", + "extensionAttributes": [], + "name": "NCI_2_2", + "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_16", + "extensionAttributes": [], + "name": "NCI_3", + "text": "

See section 3 Selection of Patients.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_17", + "extensionAttributes": [], + "name": "NCI_3_1", + "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n\u2022\n\u2022

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n\u2022

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage \u2265 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

total white blood cell count (leukocytes, WBC) \u2265 3.0 x 109/L, absolute\nneutrophil count (ANC) \u2265 1.5 x 109/L and platelet count \u2265 100 x 109/L\nhemoglobin \u2265 9 g/dL\nserum bilirubin \u2264 1.5 x ULN\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\nserum creatinine \u2264 1.5 x ULN\nserum albumin \u2265 3 g/dL\nfasting serum cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND fasting\ntriglycerides \u2264 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR \u2264 1.5 (Anticoagulation is allowed if target INR \u2264 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin \u2264 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as \u2265 20 mm by chest x-ray, as \u2265\n10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n\u2022

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

\u2022

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

\u2022

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient\u2019s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_18", + "extensionAttributes": [], + "name": "NCI_4", + "text": "

See section 4 Randomization Procedures.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_19", + "extensionAttributes": [], + "name": "NCI_4_1", + "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_20", + "extensionAttributes": [], + "name": "NCI_4_2", + "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_21", + "extensionAttributes": [], + "name": "NCI_4_3", + "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin \u2264 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_22", + "extensionAttributes": [], + "name": "NCI_5", + "text": "

See section 5 Treatment Plan.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_23", + "extensionAttributes": [], + "name": "NCI_5_1", + "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_24", + "extensionAttributes": [], + "name": "NCI_5_2", + "text": "

See section 5.2 Dosing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_25", + "extensionAttributes": [], + "name": "NCI_5_2_1", + "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_26", + "extensionAttributes": [], + "name": "NCI_5_2_2", + "text": "
\n

\u2022

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

\u2022

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

\u2022

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

\u2022

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

\u2022

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

\u2022

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

\u2022

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_27", + "extensionAttributes": [], + "name": "NCI_5_3", + "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_28", + "extensionAttributes": [], + "name": "NCI_5_3_1", + "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n\u2022

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

\u2022

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is \u2264 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

\u2022

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

\u2022

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

\u2022

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

\u2022

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nIf resolution occurs within \u2264 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade \u2264 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, \u2265 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade \u22641

\n

(platelets <50, \u2265 25 x 10 /L)

\n

If resolution occurs \u2264 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, \u2265 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade \u2264 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade \u22641 or baseline\nvalue\nIf AE resolution occurs \u2264 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade \u2264 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade \u2264 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_29", + "extensionAttributes": [], + "name": "NCI_5_3_2", + "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for \u2265 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence \u2265 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence \u2265 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator\u2019s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

\u2264 baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n\u2264 baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n\u2022

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

\u2022

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered \u2018cured\u2019).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n\u02c32 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed \u201cmiracle mouth wash\u2019\u2019 QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using \u201cmiracle mouthwash\u2019\u2019.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and \u201cmiracle mouth wash\u201d.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and \u201cmiracle mouth wash\u201d\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase\u00ae) or Periogard\u00ae oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol\u2013containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to \u2264 grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade \u2264\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to \u2264 grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade \u2264 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to \u2264\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_30", + "extensionAttributes": [], + "name": "NCI_5_3_3", + "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken \u2264 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_31", + "extensionAttributes": [], + "name": "NCI_5_3_4", + "text": "
\n

The following restrictions apply during the entire duration of the study:\n\u2022

\n

No other investigational therapy should be given to patients.

\n

\u2022

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

\u2022

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

\u2022

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

\u2022

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

\u2022

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

\u2022

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

\u2022

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

\u2022

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

\u2022

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John\u2019s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week\u2019s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient\u2019s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_32", + "extensionAttributes": [], + "name": "NCI_5_3_5", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_33", + "extensionAttributes": [], + "name": "NCI_5_4", + "text": "

See section 5.4 Supportive Care.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_34", + "extensionAttributes": [], + "name": "NCI_5_5", + "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to \u2264 grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_35", + "extensionAttributes": [], + "name": "NCI_5_6", + "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n\u2022

\n

Withdrawal of the patient\u2019s consent (patient\u2019s decision to withdraw for any reason)

\n

\u2022

\n

Termination of the study by PrECOG

\n

\u2022

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

\u2022

\n

Inability to comply with protocol

\n

\u2022

\n

Discretion of the investigator

\n

\u2022

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_36", + "extensionAttributes": [], + "name": "NCI_6", + "text": "

See section 6 Measurement of Effect.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_37", + "extensionAttributes": [], + "name": "NCI_6_1", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_38", + "extensionAttributes": [], + "name": "NCI_6_1_1", + "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_39", + "extensionAttributes": [], + "name": "NCI_6_1_2", + "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n\u2022

\n

\u2265 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

\u2022

\n

\u2265 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

\u2022

\n

\u2265 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be \u2265 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with \u2265 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n\u2018Cystic lesions\u2019 thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_40", + "extensionAttributes": [], + "name": "NCI_6_1_3", + "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and \u2265 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n\u2022\n\u2022

\n

\u2022

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A \u2018positive\u2019 FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest \u201cincrease\u201d in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from \u201ctrace\u201d to\n\u201clarge\u201d, an increase in nodal disease from \u201clocalized\u201d to \u201cwidespread\u201d, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of \u201cnon-target\u201d lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient\u2019s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n\u201csymptomatic deterioration\u201d. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*\u2018Non-CR/Non-PD\u2019 is preferred over \u2018stable disease\u2019 for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_41", + "extensionAttributes": [], + "name": "NCI_6_1_4", + "text": "

See section 6.1.4 Response Criteria.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_42", + "extensionAttributes": [], + "name": "NCI_6_1_5", + "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_43", + "extensionAttributes": [], + "name": "NCI_6_1_6", + "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN \u2264 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

\u00a3

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

\u00a3

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: \u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: \u2264 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNAPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n\u00a3 Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_44", + "extensionAttributes": [], + "name": "NCI_7", + "text": "

See section 7 Study Parameters.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_45", + "extensionAttributes": [], + "name": "NCI_7_1", + "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_46", + "extensionAttributes": [], + "name": "NCI_7_1_1", + "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin \u2264 4 weeks of randomization to protocol therapy:\n\u2022

\n

Medical history

\n

\u2022

\n

Assessment of baseline signs and symptoms

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

\u2022

\n

PT with INR

\n

\u2022

\n

Urinalysis

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n\u2022 known or suspected past hepatitis B infection\n\u2022 blood transfusion(s) prior to 1990\n\u2022 current or prior IV drug users\n\u2022 current or prior dialysis\n\u2022 household contact with hepatitis B infected patient(s)\n\u2022 current or prior high-risk sexual activity\n\u2022 body piercing or tattoos\n\u2022 mother known to have hepatitis B\n\u2022 history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon \u2018curative\u2019 treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_47", + "extensionAttributes": [], + "name": "NCI_7_1_2", + "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within \u2264 7 days of Cycle 1 Day 1.

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

\u2022

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

\u2022

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_48", + "extensionAttributes": [], + "name": "NCI_7_1_3", + "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to \u2264 grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

\u2022

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_49", + "extensionAttributes": [], + "name": "NCI_7_1_4", + "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until \u2264 grade 1\nor if the grade is >1, the event must be permanent and stable.\n\u2022

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

\u2022

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n\u2022

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_50", + "extensionAttributes": [], + "name": "NCI_7_1_5", + "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264 grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_51", + "extensionAttributes": [], + "name": "NCI_8", + "text": "

See section 8 Drug Formulation and Procurement.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_52", + "extensionAttributes": [], + "name": "NCI_8_1", + "text": "

See section 8.1 Everolimus.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_53", + "extensionAttributes": [], + "name": "NCI_8_1_1", + "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_54", + "extensionAttributes": [], + "name": "NCI_8_1_2", + "text": "
\n

Everolimus should be stored at room temperature between 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n\u2022

\n

Everolimus/placebo dose may be taken with or without food.

\n

\u2022

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

\u2022

\n

Vomited doses should not be replaced.

\n

\u2022

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_55", + "extensionAttributes": [], + "name": "NCI_8_1_3", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_56", + "extensionAttributes": [], + "name": "NCI_8_1_4", + "text": "
\n

The most common adverse reactions (incidence \u2265 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence \u2265 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
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\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n\u2022

\n

Amount received and placed in storage area.

\n

\u2022

\n

Amount currently in storage area.

\n

\u2022

\n

Label ID number or batch number.

\n

\u2022

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

\u2022

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

\u2022

\n

Amount transferred to another area for dispensing or storage.

\n

\u2022

\n

Non-study disposition (e.g., wasted, broken).

\n

\u2022

\n

Amount returned to manufacturer, if applicable

\n

\u2022

\n

Amount destroyed at study site, if applicable

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_58", + "extensionAttributes": [], + "name": "NCI_8_1_6", + "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site\u2019s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_59", + "extensionAttributes": [], + "name": "NCI_8_2", + "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide\u2122) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2\u00b0-8\u00b0C (36\u00b0-46\u00b0F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex\u00ae Package Insert 1621903 Rev 12/11)\n\u2022 Remove the glass syringe barrel from tray and check that it is not damaged\n\u2022 Remove perforated patient record label from syringe\n\u2022 Peel open the safety needle outer packaging.\n\u2022 Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n\u2022 Twist to lock the needle to the luer container.\n\u2022 Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n\u2022 Remove excess gas from the syringe.\n\u2022 Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle \u2018bevel up\u2019 position is\norientated to the lever arm (Figure 3).\n\u2022 Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n\u2022 Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n\u2022 If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n\u2022 Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex\u00ae treatment groups,\nregardless of the investigator\u2019s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex\u00ae and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex\u00ae If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher\u2019s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_60", + "extensionAttributes": [], + "name": "NCI_9", + "text": "

See section 9 Statistical Considerations.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_61", + "extensionAttributes": [], + "name": "NCI_9_1", + "text": "

See section 9.1 Primary Endpoint Analysis.

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\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
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\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
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\n

10 Adverse Event Reporting

\n
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\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator\u2019s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n\u2022

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

\u2022

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

\u2022

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

\u2022

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

\u2022

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories \u2018Definite\u2019, \u2018probable\u2019 and \u2018possible\u2019 are considered study drug related.\nCategories \u2018not likely\u2019 and \u2018not related\u2019 are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
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\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
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\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n\u2022

\n

results in death,

\n

\u2022

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

\u2022

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

\u2022

\n

results in persistent or significant disability/incapacity,

\n

\u2022

\n

is a congenital anomaly/birth defect,

\n

\u2022

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
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\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator\u2019s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM \u2013 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE\u2019s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_69", + "extensionAttributes": [], + "name": "NCI_10_3", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_70", + "extensionAttributes": [], + "name": "NCI_11", + "text": "
\n

11 Administrative

\n
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\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_72", + "extensionAttributes": [], + "name": "NCI_11_2", + "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_73", + "extensionAttributes": [], + "name": "NCI_11_3", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_74", + "extensionAttributes": [], + "name": "NCI_11_4", + "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_75", + "extensionAttributes": [], + "name": "NCI_11_5", + "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_76", + "extensionAttributes": [], + "name": "NCI_11_6", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
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\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
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\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n\u2022\n\u2022\n\u2022

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_79", + "extensionAttributes": [], + "name": "NCI_12", + "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n\u00b0C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

\u00b5M\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

\u00b5g

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_80", + "extensionAttributes": [], + "name": "NCI_13", + "text": "
\n

13 Appendix A: Eligibility Checklist\n\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n\u2264 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) \u2265 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) \u2265 1.5 x 10 /L and platelet count \u2265 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin \u2265 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin \u2264 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine \u2264 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin \u2265 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND Fasting Triglycerides \u2264 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR \u2264 1.5. (Anticoagulation is allowed if target INR \u2264 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n\u2265 20 mm by chest x-ray, as \u2265 10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n\u2022 Bisphosphonates, Zometa or Xgeva for bone metastases\n\u2022 Hormonal therapy (e.g., AI, Tamoxifen)\n\u2022 a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient\u2019s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_81", + "extensionAttributes": [], + "name": "NCI_14", + "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_82", + "extensionAttributes": [], + "name": "NCI_15", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John\u2019s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John\u2019s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John\u2019s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA\u2019s\n\u201cGuidance for Industry, Drug Interaction Studies\u201d, the University of Washington\u2019s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_83", + "extensionAttributes": [], + "name": "NCI_16", + "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient\u2019s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
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17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

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18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
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\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex\u00ae) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO\u2019Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses\u2019 Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator\u2019s Statement\n1.

\n

I have carefully read this protocol entitled \u201cRandomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014\u201d (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
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See section 20 Investigator's Statement.

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"decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_53", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_1", + "extensionAttributes": [], + "name": "SCREEN1", + "label": "Screen 1", + "description": "Screen 1 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_2", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_1", + "Activity_2", + "Activity_3", + 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{ + "id": "ScheduledActivityInstance_5", + "extensionAttributes": [], + "name": "WEEK4", + "label": "Week 4", + "description": "Week 4 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_6", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_5" + }, + { + "id": "ScheduledActivityInstance_6", + "extensionAttributes": [], + "name": "WEEK6", + "label": "Week 6", + "description": "Week 6 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_7", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_6" + }, + { + "id": "ScheduledActivityInstance_7", + "extensionAttributes": [], + "name": "WEEK8", + "label": "Week 8", + "description": "Week 8 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_8", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_31", + "Activity_31", + "Activity_32", + "Activity_32", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_7" + }, + { + "id": "ScheduledActivityInstance_8", + "extensionAttributes": [], + "name": "WEEK8N", + "label": "Week 8 NPI", + "description": "Week 8 NPI Activity Instance", + "defaultConditionId": 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"extensionAttributes": [], + "name": "WEEK16", + "label": "Week 16", + "description": "Week 16", + "defaultConditionId": "ScheduledActivityInstance_22", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_22", + "extensionAttributes": [], + "name": "WEEK16N", + "label": "Week 16 NPI", + "description": "Week 16 NPI", + "defaultConditionId": "ScheduledActivityInstance_23", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_23", + "extensionAttributes": [], + "name": "WEEK20", + "label": "Week 20", + "description": "Week 20", + "defaultConditionId": "ScheduledActivityInstance_24", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_26", + 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"defaultConditionId": null, + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [ + { + "id": "Condition_1", + "extensionAttributes": [], + "condition": "is not null", + "conditionTargetId": "ScheduledActivityInstance_3", + "instanceType": "Condition" + } + ] + }, + { + "id": "ScheduledDecisionInstance_2", + "extensionAttributes": [], + "name": "test_2", + "label": "test_2", + "description": "test_2", + "defaultConditionId": "blahblahblah", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + }, + { + "id": "ScheduledDecisionInstance_3", + "extensionAttributes": [], + "name": "test3", + "label": "test3", + "description": "test3", + "defaultConditionId": "ScheduledActivityInstance_11", + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + }, + { + "id": 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Published 2001 by Psychological Assessment Resources, Inc. 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See section 1 Introduction.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_2", + "extensionAttributes": [], + "name": "NCI_1_1", + "text": "
\n

1.1

\n

Background and Rationale

\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor \u03b1 activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell\u2019s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole \u2265 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_3", + "extensionAttributes": [], + "name": "NCI_1_2", + "text": "
\n

1.2

\n

Breast Cancer

\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_4", + "extensionAttributes": [], + "name": "NCI_1_3", + "text": "
\n

1.3

\n

Endocrine Therapy for Breast Cancer

\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_5", + "extensionAttributes": [], + "name": "NCI_1_3_1", + "text": "
\n

1.3.1

\n

Fulvestrant for Post Menopausal Women with Breast Cancer

\n

Fulvestrant (Faslodex\u00ae, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex\u00ae\n(fulvestrant) Injection for \u201c\u2026the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy\u201d.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_6", + "extensionAttributes": [], + "name": "NCI_1_3_2", + "text": "
\n

1.3.2

\n

Fulvestrant for Aromatase Inhibitor (AI) Resistant Disease

\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_7", + "extensionAttributes": [], + "name": "NCI_1_3_3", + "text": "
\n

1.3.3

\n

Rationale for Fulvestrant for this Trial

\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_8", + "extensionAttributes": [], + "name": "NCI_1_4", + "text": "
\n

1.4

\n

Everolimus (RAD001)

\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican\u00ae) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress\u00ae) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor\u00ae and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor\u00ae received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia\u00ae in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor\u00ae was\napproved for \u201cprogressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease\u201d in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor\u00ae received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor\u00ae received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n\u2022

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

\u2022

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_9", + "extensionAttributes": [], + "name": "NCI_1_4_1", + "text": "
\n

1.4.1

\n

mTOR Pathway and Mechanism of Action

\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n\u2022\n\u2022\n\u2022

\n

\u2022\n\u2022

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n\u2022

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

\u2022

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 \u03bcM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or \u2018resistant\u2019 (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_10", + "extensionAttributes": [], + "name": "NCI_1_4_2", + "text": "
\n

1.4.2

\n

Pre-Clinical Safety

\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator\u2019s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-\u03c4 is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-\u03c4 and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator\u2019s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator\u2019s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican\u00ae, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress\u00ae) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator\u2019s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor\u00ae for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n\u2022\n\u2022\n\u2022\n\u2022

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor\u00ae) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence \u2265 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence \u2265\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence \u2265 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence \u2265 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator\u2019s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_11", + "extensionAttributes": [], + "name": "NCI_1_4_3", + "text": "

See section 1.4.3 Clinical Experience.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_12", + "extensionAttributes": [], + "name": "NCI_1_5", + "text": "
\n

1.5

\n

Rationale and Study Design

\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_13", + "extensionAttributes": [], + "name": "NCI_2", + "text": "

See section 2 Objectives.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_14", + "extensionAttributes": [], + "name": "NCI_2_1", + "text": "
\n

2.1

\n

Primary Objective

\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_15", + "extensionAttributes": [], + "name": "NCI_2_2", + "text": "
\n

2.2

\n

Secondary Objectives

\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_16", + "extensionAttributes": [], + "name": "NCI_3", + "text": "

See section 3 Selection of Patients.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_17", + "extensionAttributes": [], + "name": "NCI_3_1", + "text": "
\n

3.1

\n

Eligibility Criteria

\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n\u2022\n\u2022

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n\u2022

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage \u2265 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

total white blood cell count (leukocytes, WBC) \u2265 3.0 x 109/L, absolute\nneutrophil count (ANC) \u2265 1.5 x 109/L and platelet count \u2265 100 x 109/L\nhemoglobin \u2265 9 g/dL\nserum bilirubin \u2264 1.5 x ULN\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\nserum creatinine \u2264 1.5 x ULN\nserum albumin \u2265 3 g/dL\nfasting serum cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND fasting\ntriglycerides \u2264 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR \u2264 1.5 (Anticoagulation is allowed if target INR \u2264 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin \u2264 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as \u2265 20 mm by chest x-ray, as \u2265\n10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n\u2022

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

\u2022

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

\u2022

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient\u2019s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_18", + "extensionAttributes": [], + "name": "NCI_4", + "text": "

See section 4 Randomization Procedures.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_19", + "extensionAttributes": [], + "name": "NCI_4_1", + "text": "
\n

4.1

\n

Ethics

\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_20", + "extensionAttributes": [], + "name": "NCI_4_2", + "text": "
\n

4.2

\n

Regulatory Requirements

\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_21", + "extensionAttributes": [], + "name": "NCI_4_3", + "text": "
\n

4.3

\n

Patient Randomization

\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin \u2264 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_22", + "extensionAttributes": [], + "name": "NCI_5", + "text": "

See section 5 Treatment Plan.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_23", + "extensionAttributes": [], + "name": "NCI_5_1", + "text": "
\n

5.1

\n

Administration Schedule

\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_24", + "extensionAttributes": [], + "name": "NCI_5_2", + "text": "
\n

5.2

\n

Dosing and Administration

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_25", + "extensionAttributes": [], + "name": "NCI_5_2_1", + "text": "
\n

5.2.1

\n

Fulvestrant (Arm A and Arm B)

\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_26", + "extensionAttributes": [], + "name": "NCI_5_2_2", + "text": "
\n

5.2.2

\n

Everolimus or Placebo (Arm A and Arm B)

\n

\u2022

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

\u2022

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

\u2022

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

\u2022

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

\u2022

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

\u2022

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

\u2022

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_27", + "extensionAttributes": [], + "name": "NCI_5_3", + "text": "
\n

5.3

\n

Dose Modifications and Toxicity Management

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_28", + "extensionAttributes": [], + "name": "NCI_5_3_1", + "text": "
\n

5.3.1

\n

Dose Modifications General Guidelines for Everolimus/\nPlacebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n\u2022

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

\u2022

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is \u2264 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

\u2022

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

\u2022

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

\u2022

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

\u2022

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nIf resolution occurs within \u2264 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade \u2264 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, \u2265 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade \u22641

\n

(platelets <50, \u2265 25 x 10 /L)

\n

If resolution occurs \u2264 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, \u2265 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade \u2264 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade \u22641 or baseline\nvalue\nIf AE resolution occurs \u2264 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade \u2264 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade \u2264 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_29", + "extensionAttributes": [], + "name": "NCI_5_3_2", + "text": "
\n

5.3.2

\n

Common Adverse Events Associated with Everolimus

\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for \u2265 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence \u2265 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence \u2265 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator\u2019s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

\u2264 baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n\u2264 baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n\u2022

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

\u2022

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered \u2018cured\u2019).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n\u02c32 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed \u201cmiracle mouth wash\u2019\u2019 QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using \u201cmiracle mouthwash\u2019\u2019.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and \u201cmiracle mouth wash\u201d.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and \u201cmiracle mouth wash\u201d\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase\u00ae) or Periogard\u00ae oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol\u2013containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to \u2264 grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade \u2264\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to \u2264 grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade \u2264 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to \u2264\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_30", + "extensionAttributes": [], + "name": "NCI_5_3_3", + "text": "
\n

5.3.3

\n

Concomitant Therapies

\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken \u2264 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_31", + "extensionAttributes": [], + "name": "NCI_5_3_4", + "text": "
\n

5.3.4

\n

Prohibited Therapies and Restrictions

\n

The following restrictions apply during the entire duration of the study:\n\u2022

\n

No other investigational therapy should be given to patients.

\n

\u2022

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

\u2022

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

\u2022

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

\u2022

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

\u2022

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

\u2022

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

\u2022

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

\u2022

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

\u2022

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John\u2019s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week\u2019s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient\u2019s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_32", + "extensionAttributes": [], + "name": "NCI_5_3_5", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_33", + "extensionAttributes": [], + "name": "NCI_5_4", + "text": "

See section 5.4 Supportive Care.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_34", + "extensionAttributes": [], + "name": "NCI_5_5", + "text": "
\n

5.5

\n

Duration of Therapy

\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to \u2264 grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_35", + "extensionAttributes": [], + "name": "NCI_5_6", + "text": "
\n

5.6

\n

Withdrawal of Patients from Study

\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n\u2022

\n

Withdrawal of the patient\u2019s consent (patient\u2019s decision to withdraw for any reason)

\n

\u2022

\n

Termination of the study by PrECOG

\n

\u2022

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

\u2022

\n

Inability to comply with protocol

\n

\u2022

\n

Discretion of the investigator

\n

\u2022

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_36", + "extensionAttributes": [], + "name": "NCI_6", + "text": "

See section 6 Measurement of Effect.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_37", + "extensionAttributes": [], + "name": "NCI_6_1", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_38", + "extensionAttributes": [], + "name": "NCI_6_1_1", + "text": "
\n

6.1.1

\n

Definitions

\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_39", + "extensionAttributes": [], + "name": "NCI_6_1_2", + "text": "
\n

6.1.2

\n

Disease Parameters

\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n\u2022

\n

\u2265 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

\u2022

\n

\u2265 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

\u2022

\n

\u2265 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be \u2265 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with \u2265 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n\u2018Cystic lesions\u2019 thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_40", + "extensionAttributes": [], + "name": "NCI_6_1_3", + "text": "
\n

6.1.3

\n

Methods for Evaluation of Measurable Disease

\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and \u2265 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n\u2022\n\u2022

\n

\u2022

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A \u2018positive\u2019 FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest \u201cincrease\u201d in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from \u201ctrace\u201d to\n\u201clarge\u201d, an increase in nodal disease from \u201clocalized\u201d to \u201cwidespread\u201d, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of \u201cnon-target\u201d lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient\u2019s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n\u201csymptomatic deterioration\u201d. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*\u2018Non-CR/Non-PD\u2019 is preferred over \u2018stable disease\u2019 for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_41", + "extensionAttributes": [], + "name": "NCI_6_1_4", + "text": "

See section 6.1.4 Response Criteria.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_42", + "extensionAttributes": [], + "name": "NCI_6_1_5", + "text": "
\n

6.1.5

\n

Duration of Response

\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_43", + "extensionAttributes": [], + "name": "NCI_6_1_6", + "text": "
\n

6.1.6

\n

Progression-Free Survival

\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN \u2264 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

\u00a3

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

\u00a3

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: \u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: \u2264 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNAPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n\u00a3 Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_44", + "extensionAttributes": [], + "name": "NCI_7", + "text": "

See section 7 Study Parameters.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_45", + "extensionAttributes": [], + "name": "NCI_7_1", + "text": "
\n

7.1

\n

Procedures by Visit

\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_46", + "extensionAttributes": [], + "name": "NCI_7_1_1", + "text": "
\n

7.1.1

\n

Pre-Study

\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin \u2264 4 weeks of randomization to protocol therapy:\n\u2022

\n

Medical history

\n

\u2022

\n

Assessment of baseline signs and symptoms

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

\u2022

\n

PT with INR

\n

\u2022

\n

Urinalysis

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n\u2022 known or suspected past hepatitis B infection\n\u2022 blood transfusion(s) prior to 1990\n\u2022 current or prior IV drug users\n\u2022 current or prior dialysis\n\u2022 household contact with hepatitis B infected patient(s)\n\u2022 current or prior high-risk sexual activity\n\u2022 body piercing or tattoos\n\u2022 mother known to have hepatitis B\n\u2022 history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon \u2018curative\u2019 treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_47", + "extensionAttributes": [], + "name": "NCI_7_1_2", + "text": "
\n

7.1.2

\n

Induction Phase (fulvestrant + everolimus/placebo)

\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within \u2264 7 days of Cycle 1 Day 1.

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

\u2022

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

\u2022

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_48", + "extensionAttributes": [], + "name": "NCI_7_1_3", + "text": "
\n

7.1.3

\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to \u2264 grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

\u2022

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_49", + "extensionAttributes": [], + "name": "NCI_7_1_4", + "text": "
\n

7.1.4

\n

Continuation Phase (fulvestrant +/- everolimus)

\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until \u2264 grade 1\nor if the grade is >1, the event must be permanent and stable.\n\u2022

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

\u2022

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n\u2022

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_50", + "extensionAttributes": [], + "name": "NCI_7_1_5", + "text": "
\n

7.1.5

\n

Follow-Up Off-Therapy

\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264 grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_51", + "extensionAttributes": [], + "name": "NCI_8", + "text": "

See section 8 Drug Formulation and Procurement.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_52", + "extensionAttributes": [], + "name": "NCI_8_1", + "text": "
\n

8.1

\n

Everolimus

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_53", + "extensionAttributes": [], + "name": "NCI_8_1_1", + "text": "
\n

8.1.1

\n

Packaging and Labeling

\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_54", + "extensionAttributes": [], + "name": "NCI_8_1_2", + "text": "
\n

8.1.2

\n

Storage Requirements/Stability

\n

Everolimus should be stored at room temperature between 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n\u2022

\n

Everolimus/placebo dose may be taken with or without food.

\n

\u2022

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

\u2022

\n

Vomited doses should not be replaced.

\n

\u2022

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_55", + "extensionAttributes": [], + "name": "NCI_8_1_3", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_56", + "extensionAttributes": [], + "name": "NCI_8_1_4", + "text": "
\n

8.1.4

\n

Side Effects

\n

The most common adverse reactions (incidence \u2265 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence \u2265 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_57", + "extensionAttributes": [], + "name": "NCI_8_1_5", + "text": "
\n

8.1.5

\n

Investigational Product Records at Investigational Site(s)

\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n\u2022

\n

Amount received and placed in storage area.

\n

\u2022

\n

Amount currently in storage area.

\n

\u2022

\n

Label ID number or batch number.

\n

\u2022

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

\u2022

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

\u2022

\n

Amount transferred to another area for dispensing or storage.

\n

\u2022

\n

Non-study disposition (e.g., wasted, broken).

\n

\u2022

\n

Amount returned to manufacturer, if applicable

\n

\u2022

\n

Amount destroyed at study site, if applicable

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_58", + "extensionAttributes": [], + "name": "NCI_8_1_6", + "text": "
\n

8.1.6

\n

Return and Destruction of Investigational Product

\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site\u2019s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_59", + "extensionAttributes": [], + "name": "NCI_8_2", + "text": "
\n

8.2

\n

Fulvestrant (Faslodex\uf6da)\n8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide\u2122) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2\u00b0-8\u00b0C (36\u00b0-46\u00b0F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex\u00ae Package Insert 1621903 Rev 12/11)\n\u2022 Remove the glass syringe barrel from tray and check that it is not damaged\n\u2022 Remove perforated patient record label from syringe\n\u2022 Peel open the safety needle outer packaging.\n\u2022 Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n\u2022 Twist to lock the needle to the luer container.\n\u2022 Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n\u2022 Remove excess gas from the syringe.\n\u2022 Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle \u2018bevel up\u2019 position is\norientated to the lever arm (Figure 3).\n\u2022 Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n\u2022 Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n\u2022 If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n\u2022 Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex\u00ae treatment groups,\nregardless of the investigator\u2019s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex\u00ae and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex\u00ae If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher\u2019s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_60", + "extensionAttributes": [], + "name": "NCI_9", + "text": "

See section 9 Statistical Considerations.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_61", + "extensionAttributes": [], + "name": "NCI_9_1", + "text": "

See section 9.1 Primary Endpoint Analysis.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_62", + "extensionAttributes": [], + "name": "NCI_9_2", + "text": "
\n

9.2

\n

Safety Analyses

\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_63", + "extensionAttributes": [], + "name": "NCI_9_3", + "text": "
\n

9.3

\n

Analyses of Other Secondary Endpoints

\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_64", + "extensionAttributes": [], + "name": "NCI_10", + "text": "
\n

10 Adverse Event Reporting

\n
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\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator\u2019s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n\u2022

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

\u2022

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

\u2022

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

\u2022

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

\u2022

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories \u2018Definite\u2019, \u2018probable\u2019 and \u2018possible\u2019 are considered study drug related.\nCategories \u2018not likely\u2019 and \u2018not related\u2019 are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_66", + "extensionAttributes": [], + "name": "NCI_10_2", + "text": "
\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
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\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n\u2022

\n

results in death,

\n

\u2022

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

\u2022

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

\u2022

\n

results in persistent or significant disability/incapacity,

\n

\u2022

\n

is a congenital anomaly/birth defect,

\n

\u2022

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_68", + "extensionAttributes": [], + "name": "NCI_10_2_2", + "text": "
\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator\u2019s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM \u2013 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE\u2019s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_69", + "extensionAttributes": [], + "name": "NCI_10_3", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_70", + "extensionAttributes": [], + "name": "NCI_11", + "text": "
\n

11 Administrative

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_71", + "extensionAttributes": [], + "name": "NCI_11_1", + "text": "
\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_72", + "extensionAttributes": [], + "name": "NCI_11_2", + "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_73", + "extensionAttributes": [], + "name": "NCI_11_3", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_74", + "extensionAttributes": [], + "name": "NCI_11_4", + "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_75", + "extensionAttributes": [], + "name": "NCI_11_5", + "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_76", + "extensionAttributes": [], + "name": "NCI_11_6", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_77", + "extensionAttributes": [], + "name": "NCI_11_7", + "text": "
\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_78", + "extensionAttributes": [], + "name": "NCI_11_8", + "text": "
\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n\u2022\n\u2022\n\u2022

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_79", + "extensionAttributes": [], + "name": "NCI_12", + "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n\u00b0C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

\u00b5M\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

\u00b5g

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_80", + "extensionAttributes": [], + "name": "NCI_13", + "text": "
\n

13 Appendix A: Eligibility Checklist\n\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n\u2264 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) \u2265 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) \u2265 1.5 x 10 /L and platelet count \u2265 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin \u2265 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin \u2264 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine \u2264 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin \u2265 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND Fasting Triglycerides \u2264 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR \u2264 1.5. (Anticoagulation is allowed if target INR \u2264 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n\u2265 20 mm by chest x-ray, as \u2265 10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n\u2022 Bisphosphonates, Zometa or Xgeva for bone metastases\n\u2022 Hormonal therapy (e.g., AI, Tamoxifen)\n\u2022 a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient\u2019s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_81", + "extensionAttributes": [], + "name": "NCI_14", + "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_82", + "extensionAttributes": [], + "name": "NCI_15", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John\u2019s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John\u2019s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John\u2019s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA\u2019s\n\u201cGuidance for Industry, Drug Interaction Studies\u201d, the University of Washington\u2019s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_83", + "extensionAttributes": [], + "name": "NCI_16", + "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient\u2019s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
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\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
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\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
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\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex\u00ae) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO\u2019Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses\u2019 Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator\u2019s Statement\n1.

\n

I have carefully read this protocol entitled \u201cRandomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014\u201d (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
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See section 20 Investigator's Statement.

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Protocol therapy must begin within 7 working days of randomization.", + "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_2", + "extensionAttributes": [], + "name": "INDUCTION_EVE_FUL", + "label": "Induction: Fulvestrant + Everolimus", + "description": "Induction treatment for Arm A: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus everolimus 10 mg PO daily, 28-day cycles, max 12 cycles.", + "transitionStartRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "Induction Phase Entry", + "label": "Induction Phase Entry", + "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Induction Phase Exit", + "label": "Induction Phase Exit", + "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_3", + "extensionAttributes": [], + "name": "INDUCTION_PBO_FUL", + "label": "Induction: Fulvestrant + Placebo", + "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", + "transitionStartRule": { + "id": "TransitionRule_2", + "extensionAttributes": [], + "name": "Induction Phase Entry", + "label": "Induction Phase Entry", + "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_3", + "extensionAttributes": [], + "name": "Induction Phase Exit", + "label": "Induction Phase Exit", + "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_4" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_4", + "extensionAttributes": [], + "name": "CONTINUATION_EVE_FUL", + "label": "Continuation: Fulvestrant + Everolimus", + "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_3" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_5", + "extensionAttributes": [], + "name": "CONTINUATION_FUL", + "label": "Continuation: Fulvestrant alone", + "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", + "transitionStartRule": { + "id": "TransitionRule_4", + "extensionAttributes": [], + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_5", + "extensionAttributes": [], + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [ + "StudyIntervention_5" + ], + "notes": [], + "instanceType": "StudyElement" + }, + { + "id": "StudyElement_6", + "extensionAttributes": [], + "name": "FOLLOW_UP_ELEMENT", + "label": "Follow-Up Off-Therapy", + "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", + "transitionStartRule": { + "id": "TransitionRule_6", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Entry", + "label": "Follow-Up Off-Therapy Entry", + "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "instanceType": "TransitionRule" + }, + "transitionEndRule": { + "id": "TransitionRule_7", + "extensionAttributes": [], + "name": "Follow-Up Off-Therapy Exit", + "label": "Follow-Up Off-Therapy Exit", + "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "instanceType": "TransitionRule" + }, + "studyInterventionIds": [], + "notes": [], + "instanceType": "StudyElement" + } + ], + "estimands": [ + { + "id": "Estimand_1", + "extensionAttributes": [], + "name": "Estimand for Progression-Free Survival (PFS)", + "label": "Primary Estimand", + "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", + "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_1", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_1", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_2", + "extensionAttributes": [], + "name": "Discontinuation of everolimus due to toxicity", + "label": "Discontinuation of everolimus due to toxicity", + "description": null, + "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", + "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_3", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", + "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_4", + "extensionAttributes": [], + "name": "Initiation of prohibited anti-cancer therapy before progression", + "label": "Initiation of prohibited anti-cancer therapy before progression", + "description": null, + "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", + "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_2", + "extensionAttributes": [], + "name": "Estimand for Overall Survival (OS)", + "label": "Secondary Estimand \u2014 OS", + "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_2", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_5", + "extensionAttributes": [], + "name": "Discontinuation of study treatment (any reason)", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", + "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_6", + "extensionAttributes": [], + "name": "Initiation of subsequent anti-cancer therapy after progression", + "label": "Initiation of subsequent anti-cancer therapy after progression", + "description": null, + "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", + "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_7", + "extensionAttributes": [], + "name": "Withdrawal of consent or loss to follow-up", + "label": "Withdrawal of consent or loss to follow-up", + "description": null, + "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", + "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_3", + "extensionAttributes": [], + "name": "Estimand for Time to Progression (TTP)", + "label": "Secondary Estimand \u2014 TTP", + "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", + "populationSummary": "All randomized eligible patients (same as PFS estimand population).", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_3", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_8", + "extensionAttributes": [], + "name": "Death before documented progression", + "label": "Death before documented progression", + "description": null, + "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", + "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_9", + "extensionAttributes": [], + "name": "Discontinuation of study treatment", + "label": "Discontinuation of study treatment (any reason)", + "description": null, + "text": "Patient permanently discontinues study treatment before disease progression.", + "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_4", + "extensionAttributes": [], + "name": "Estimand for Objective Response Rate (ORR)", + "label": "Secondary Estimand \u2014 ORR", + "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", + "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_4", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_10", + "extensionAttributes": [], + "name": "Death or progression before first response assessment", + "label": "Death or progression before first response assessment", + "description": null, + "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", + "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_11", + "extensionAttributes": [], + "name": "Treatment discontinuation before response assessment", + "label": "Treatment discontinuation before response assessment", + "description": null, + "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", + "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_5", + "extensionAttributes": [], + "name": "Estimand for Clinical Benefit Rate (CBR)", + "label": "Secondary Estimand \u2014 CBR", + "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", + "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_5", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_12", + "extensionAttributes": [], + "name": "Death or progression before 6-month stable disease threshold", + "label": "Death or progression before 6-month stable disease threshold", + "description": null, + "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", + "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_13", + "extensionAttributes": [], + "name": "Treatment discontinuation before 6-month landmark", + "label": "Treatment discontinuation before 6-month landmark", + "description": null, + "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", + "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + }, + { + "id": "Estimand_6", + "extensionAttributes": [], + "name": "Estimand for Safety and Tolerability", + "label": "Secondary Estimand \u2014 Safety", + "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", + "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", + "analysisPopulationId": "", + "variableOfInterestId": "Endpoint_6", + "interventionIds": [ + "StudyIntervention_1", + "StudyIntervention_2" + ], + "intercurrentEvents": [ + { + "id": "IntercurrentEvent_14", + "extensionAttributes": [], + "name": "Treatment discontinuation", + "label": "Treatment discontinuation", + "description": null, + "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", + "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", + "notes": [], + "instanceType": "IntercurrentEvent" + }, + { + "id": "IntercurrentEvent_15", + "extensionAttributes": [], + "name": "Dose reduction or interruption of everolimus", + "label": "Dose reduction or interruption of everolimus", + "description": null, + "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", + "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", + "notes": [], + "instanceType": "IntercurrentEvent" + } + ], + "notes": [], + "instanceType": "Estimand" + } + ], + "indications": [ + { + "id": "Indication_1", + "extensionAttributes": [], + "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "label": "HR+ AI-Resistant Metastatic Breast Cancer", + "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", + "isRareDisease": false, + "codes": [ + { + "id": "Code_7947", + "extensionAttributes": [], + "code": "C9246", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Hormone Receptor-Positive Breast Carcinoma", + "instanceType": "Code" + }, + { + "id": "Code_7948", + "extensionAttributes": [], + "code": "C7771", + "codeSystem": "http://ncithesaurus.nci.nih.gov", + "codeSystemVersion": "24.04e", + "decode": "Metastatic Breast Carcinoma", + "instanceType": "Code" + } + ], + "notes": [], + "instanceType": "Indication" + } + ], + "studyInterventionIds": [ + "StudyIntervention_3", + "StudyIntervention_4", + "StudyIntervention_5" + ], + "objectives": [ + { + "id": "Objective_1", + "extensionAttributes": [], + "name": "Primary Objective", + "label": "Primary Objective", + "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2355", + "extensionAttributes": [], + "code": "C85826", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C85826", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_1", + "extensionAttributes": [], + "name": "Progression-Free Survival (PFS)", + "label": "Progression-Free Survival (PFS)", + "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", + "level": { + "id": "Code_2356", + "extensionAttributes": [], + "code": "C94496", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C94496", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + }, + { + "id": "Objective_2", + "extensionAttributes": [], + "name": "Secondary Objective", + "label": "Secondary Objective", + "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", + "text": "", + "dictionaryId": null, + "notes": [], + "level": { + "id": "Code_2357", + "extensionAttributes": [], + "code": "C85827", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "C85827", + "instanceType": "Code" + }, + "endpoints": [ + { + "id": "Endpoint_2", + "extensionAttributes": [], + "name": "Overall Survival (OS)", + "label": "Overall Survival (OS)", + "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize overall survival in the two treatment arms.", + "level": { + "id": "Code_2358", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_3", + "extensionAttributes": [], + "name": "Time to Progression (TTP)", + "label": "Time to Progression (TTP)", + "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To estimate and compare median time to disease progression between treatment arms.", + "level": { + "id": "Code_2359", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_4", + "extensionAttributes": [], + "name": "Objective Response Rate (ORR)", + "label": "Objective Response Rate (ORR)", + "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", + "level": { + "id": "Code_2360", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_5", + "extensionAttributes": [], + "name": "Clinical Benefit Rate (CBR)", + "label": "Clinical Benefit Rate (CBR)", + "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", + "level": { + "id": "Code_2361", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + }, + { + "id": "Endpoint_6", + "extensionAttributes": [], + "name": "Safety and Tolerability", + "label": "Safety and Tolerability", + "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", + "text": "", + "dictionaryId": null, + "notes": [], + "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", + "level": { + "id": "Code_2362", + "extensionAttributes": [], + "code": "C139173", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "", + "decode": "C139173", + "instanceType": "Code" + }, + "instanceType": "Endpoint" + } + ], + "instanceType": "Objective" + } + ], + "population": { + "id": "StudyDesignPopulation_1", + "extensionAttributes": [], + "name": "Population_1", + "label": null, + "description": null, + "includesHealthySubjects": false, + "plannedEnrollmentNumber": null, + "plannedCompletionNumber": null, + "plannedSex": [], + "criterionIds": [], + "plannedAge": null, + "notes": [], + "cohorts": [], + "instanceType": "StudyDesignPopulation" + }, + "scheduleTimelines": [ + { + "id": "ScheduleTimeline_1", + "extensionAttributes": [], + "name": "MAIN_TIMELINE", + "label": "PrE0102 Main Schedule of Activities Timeline", + "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", + "mainTimeline": true, + "entryCondition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", + "entryId": "ScheduledActivityInstance_1", + "exits": [], + "timings": [ + { + "id": "Timing_1", + "extensionAttributes": [], + "name": "C1D1_ANCHOR", + "label": "Cycle 1 Day 1 (anchor)", + "description": "Cycle 1 Day 1 (anchor)", + "type": { + "id": "Code_10080", + "extensionAttributes": [], + "code": "C201358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Fixed Reference", + "instanceType": "Code" + }, + "value": "P0D", + "valueLabel": "Day 1", + "relativeToFrom": { + "id": "Code_10081", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_2", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_2", + "extensionAttributes": [], + "name": "SCREEN_WINDOW", + "label": "Within 4 weeks before C1D1", + "description": "Within 4 weeks before C1D1", + "type": { + "id": "Code_10082", + "extensionAttributes": [], + "code": "C201357", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Before", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "Up to 28 days before", + "relativeToFrom": { + "id": "Code_10083", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_1", + "windowLower": "P0D", + "windowUpper": "P28D", + "windowLabel": "<= 4 weeks before C1D1", + "instanceType": "Timing" + }, + { + "id": "Timing_3", + "extensionAttributes": [], + "name": "C1D15_OFFSET", + "label": "14 days after C1D1", + "description": "14 days after C1D1", + "type": { + "id": "Code_10084", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P14D", + "valueLabel": "Day 15", + "relativeToFrom": { + "id": "Code_10085", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + }, + { + "id": "Timing_4", + "extensionAttributes": [], + "name": "C2D1_OFFSET", + "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "type": { + "id": "Code_10086", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10087", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_4", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_5", + "extensionAttributes": [], + "name": "C3D1_OFFSET", + "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "type": { + "id": "Code_10088", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10089", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_5", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_6", + "extensionAttributes": [], + "name": "C4D1_OFFSET", + "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "type": { + "id": "Code_10090", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10091", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_6", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_7", + "extensionAttributes": [], + "name": "C5D1_OFFSET", + "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "type": { + "id": "Code_10092", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10093", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_8", + "extensionAttributes": [], + "name": "C6D1_OFFSET", + "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10094", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_8", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_9", + "extensionAttributes": [], + "name": "C7D1_OFFSET", + "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "type": null, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10095", + 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"codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_10", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", + "windowLower": "-PT72H", + "windowUpper": "PT72H", + "windowLabel": "+/- 72 hours", + "instanceType": "Timing" + }, + { + "id": "Timing_12", + "extensionAttributes": [], + "name": "C10D1_OFFSET", + "label": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", + "description": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", + "type": { + "id": "Code_10100", + "extensionAttributes": [], + "code": "C201356", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "After", + "instanceType": "Code" + }, + "value": "P28D", + "valueLabel": "28 Days", + "relativeToFrom": { + "id": "Code_10101", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start 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See section 1 Introduction.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_2", + "extensionAttributes": [], + "name": "NCI_1_1", + "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor \u03b1 activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell\u2019s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole \u2265 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_3", + "extensionAttributes": [], + "name": "NCI_1_2", + "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_4", + "extensionAttributes": [], + "name": "NCI_1_3", + "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_5", + "extensionAttributes": [], + "name": "NCI_1_3_1", + "text": "
\n

Fulvestrant (Faslodex\u00ae, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex\u00ae\n(fulvestrant) Injection for \u201c\u2026the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy\u201d.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_6", + "extensionAttributes": [], + "name": "NCI_1_3_2", + "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

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Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

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\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican\u00ae) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress\u00ae) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor\u00ae and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor\u00ae received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia\u00ae in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor\u00ae was\napproved for \u201cprogressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease\u201d in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor\u00ae received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor\u00ae received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n\u2022

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

\u2022

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

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At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

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targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n\u2022\n\u2022\n\u2022

\n

\u2022\n\u2022

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

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inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

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Preclinical Studies

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Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n\u2022

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

\u2022

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 \u03bcM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or \u2018resistant\u2019 (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

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In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator\u2019s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-\u03c4 is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-\u03c4 and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator\u2019s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator\u2019s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican\u00ae, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress\u00ae) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator\u2019s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor\u00ae for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n\u2022\n\u2022\n\u2022\n\u2022

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor\u00ae) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence \u2265 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence \u2265\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence \u2265 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence \u2265 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator\u2019s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

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See section 1.4.3 Clinical Experience.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_12", + "extensionAttributes": [], + "name": "NCI_1_5", + "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_13", + "extensionAttributes": [], + "name": "NCI_2", + "text": "

See section 2 Objectives.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_14", + "extensionAttributes": [], + "name": "NCI_2_1", + "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_15", + "extensionAttributes": [], + "name": "NCI_2_2", + "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_16", + "extensionAttributes": [], + "name": "NCI_3", + "text": "

See section 3 Selection of Patients.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_17", + "extensionAttributes": [], + "name": "NCI_3_1", + "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n\u2022\n\u2022

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n\u2022

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage \u2265 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

total white blood cell count (leukocytes, WBC) \u2265 3.0 x 109/L, absolute\nneutrophil count (ANC) \u2265 1.5 x 109/L and platelet count \u2265 100 x 109/L\nhemoglobin \u2265 9 g/dL\nserum bilirubin \u2264 1.5 x ULN\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\nserum creatinine \u2264 1.5 x ULN\nserum albumin \u2265 3 g/dL\nfasting serum cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND fasting\ntriglycerides \u2264 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR \u2264 1.5 (Anticoagulation is allowed if target INR \u2264 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin \u2264 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as \u2265 20 mm by chest x-ray, as \u2265\n10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n\u2022

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

\u2022

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

\u2022

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient\u2019s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_18", + "extensionAttributes": [], + "name": "NCI_4", + "text": "

See section 4 Randomization Procedures.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_19", + "extensionAttributes": [], + "name": "NCI_4_1", + "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_20", + "extensionAttributes": [], + "name": "NCI_4_2", + "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_21", + "extensionAttributes": [], + "name": "NCI_4_3", + "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin \u2264 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_22", + "extensionAttributes": [], + "name": "NCI_5", + "text": "

See section 5 Treatment Plan.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_23", + "extensionAttributes": [], + "name": "NCI_5_1", + "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_24", + "extensionAttributes": [], + "name": "NCI_5_2", + "text": "

See section 5.2 Dosing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_25", + "extensionAttributes": [], + "name": "NCI_5_2_1", + "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_26", + "extensionAttributes": [], + "name": "NCI_5_2_2", + "text": "
\n

\u2022

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

\u2022

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

\u2022

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

\u2022

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

\u2022

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

\u2022

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

\u2022

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_27", + "extensionAttributes": [], + "name": "NCI_5_3", + "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_28", + "extensionAttributes": [], + "name": "NCI_5_3_1", + "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n\u2022

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

\u2022

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is \u2264 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

\u2022

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

\u2022

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

\u2022

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

\u2022

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nIf resolution occurs within \u2264 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade \u2264 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, \u2265 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade \u22641

\n

(platelets <50, \u2265 25 x 10 /L)

\n

If resolution occurs \u2264 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, \u2265 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade \u2264 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade \u22641 or baseline\nvalue\nIf AE resolution occurs \u2264 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade \u2264 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade \u2264 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_29", + "extensionAttributes": [], + "name": "NCI_5_3_2", + "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for \u2265 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence \u2265 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence \u2265 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator\u2019s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

\u2264 baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n\u2264 baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n\u2022

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

\u2022

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered \u2018cured\u2019).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n\u02c32 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed \u201cmiracle mouth wash\u2019\u2019 QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using \u201cmiracle mouthwash\u2019\u2019.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and \u201cmiracle mouth wash\u201d.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and \u201cmiracle mouth wash\u201d\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase\u00ae) or Periogard\u00ae oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol\u2013containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to \u2264 grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade \u2264\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to \u2264 grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade \u2264 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to \u2264\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_30", + "extensionAttributes": [], + "name": "NCI_5_3_3", + "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken \u2264 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_31", + "extensionAttributes": [], + "name": "NCI_5_3_4", + "text": "
\n

The following restrictions apply during the entire duration of the study:\n\u2022

\n

No other investigational therapy should be given to patients.

\n

\u2022

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

\u2022

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

\u2022

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

\u2022

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

\u2022

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

\u2022

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

\u2022

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

\u2022

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

\u2022

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John\u2019s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week\u2019s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient\u2019s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_32", + "extensionAttributes": [], + "name": "NCI_5_3_5", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_33", + "extensionAttributes": [], + "name": "NCI_5_4", + "text": "

See section 5.4 Supportive Care.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_34", + "extensionAttributes": [], + "name": "NCI_5_5", + "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to \u2264 grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_35", + "extensionAttributes": [], + "name": "NCI_5_6", + "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n\u2022

\n

Withdrawal of the patient\u2019s consent (patient\u2019s decision to withdraw for any reason)

\n

\u2022

\n

Termination of the study by PrECOG

\n

\u2022

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

\u2022

\n

Inability to comply with protocol

\n

\u2022

\n

Discretion of the investigator

\n

\u2022

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_36", + "extensionAttributes": [], + "name": "NCI_6", + "text": "

See section 6 Measurement of Effect.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_37", + "extensionAttributes": [], + "name": "NCI_6_1", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_38", + "extensionAttributes": [], + "name": "NCI_6_1_1", + "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_39", + "extensionAttributes": [], + "name": "NCI_6_1_2", + "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n\u2022

\n

\u2265 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

\u2022

\n

\u2265 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

\u2022

\n

\u2265 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be \u2265 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with \u2265 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n\u2018Cystic lesions\u2019 thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_40", + "extensionAttributes": [], + "name": "NCI_6_1_3", + "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and \u2265 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n\u2022\n\u2022

\n

\u2022

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A \u2018positive\u2019 FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest \u201cincrease\u201d in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from \u201ctrace\u201d to\n\u201clarge\u201d, an increase in nodal disease from \u201clocalized\u201d to \u201cwidespread\u201d, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of \u201cnon-target\u201d lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient\u2019s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n\u201csymptomatic deterioration\u201d. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*\u2018Non-CR/Non-PD\u2019 is preferred over \u2018stable disease\u2019 for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_41", + "extensionAttributes": [], + "name": "NCI_6_1_4", + "text": "

See section 6.1.4 Response Criteria.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_42", + "extensionAttributes": [], + "name": "NCI_6_1_5", + "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_43", + "extensionAttributes": [], + "name": "NCI_6_1_6", + "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN \u2264 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

\u00a3

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

\u00a3

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: \u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: \u2264 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNAPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n\u00a3 Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_44", + "extensionAttributes": [], + "name": "NCI_7", + "text": "

See section 7 Study Parameters.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_45", + "extensionAttributes": [], + "name": "NCI_7_1", + "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_46", + "extensionAttributes": [], + "name": "NCI_7_1_1", + "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin \u2264 4 weeks of randomization to protocol therapy:\n\u2022

\n

Medical history

\n

\u2022

\n

Assessment of baseline signs and symptoms

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

\u2022

\n

PT with INR

\n

\u2022

\n

Urinalysis

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n\u2022 known or suspected past hepatitis B infection\n\u2022 blood transfusion(s) prior to 1990\n\u2022 current or prior IV drug users\n\u2022 current or prior dialysis\n\u2022 household contact with hepatitis B infected patient(s)\n\u2022 current or prior high-risk sexual activity\n\u2022 body piercing or tattoos\n\u2022 mother known to have hepatitis B\n\u2022 history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon \u2018curative\u2019 treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_47", + "extensionAttributes": [], + "name": "NCI_7_1_2", + "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within \u2264 7 days of Cycle 1 Day 1.

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

\u2022

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

\u2022

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_48", + "extensionAttributes": [], + "name": "NCI_7_1_3", + "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to \u2264 grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

\u2022

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_49", + "extensionAttributes": [], + "name": "NCI_7_1_4", + "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until \u2264 grade 1\nor if the grade is >1, the event must be permanent and stable.\n\u2022

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

\u2022

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n\u2022

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_50", + "extensionAttributes": [], + "name": "NCI_7_1_5", + "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264 grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_51", + "extensionAttributes": [], + "name": "NCI_8", + "text": "

See section 8 Drug Formulation and Procurement.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_52", + "extensionAttributes": [], + "name": "NCI_8_1", + "text": "

See section 8.1 Everolimus.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_53", + "extensionAttributes": [], + "name": "NCI_8_1_1", + "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_54", + "extensionAttributes": [], + "name": "NCI_8_1_2", + "text": "
\n

Everolimus should be stored at room temperature between 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n\u2022

\n

Everolimus/placebo dose may be taken with or without food.

\n

\u2022

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

\u2022

\n

Vomited doses should not be replaced.

\n

\u2022

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_55", + "extensionAttributes": [], + "name": "NCI_8_1_3", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_56", + "extensionAttributes": [], + "name": "NCI_8_1_4", + "text": "
\n

The most common adverse reactions (incidence \u2265 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence \u2265 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
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\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n\u2022

\n

Amount received and placed in storage area.

\n

\u2022

\n

Amount currently in storage area.

\n

\u2022

\n

Label ID number or batch number.

\n

\u2022

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

\u2022

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

\u2022

\n

Amount transferred to another area for dispensing or storage.

\n

\u2022

\n

Non-study disposition (e.g., wasted, broken).

\n

\u2022

\n

Amount returned to manufacturer, if applicable

\n

\u2022

\n

Amount destroyed at study site, if applicable

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_58", + "extensionAttributes": [], + "name": "NCI_8_1_6", + "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site\u2019s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_59", + "extensionAttributes": [], + "name": "NCI_8_2", + "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide\u2122) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2\u00b0-8\u00b0C (36\u00b0-46\u00b0F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex\u00ae Package Insert 1621903 Rev 12/11)\n\u2022 Remove the glass syringe barrel from tray and check that it is not damaged\n\u2022 Remove perforated patient record label from syringe\n\u2022 Peel open the safety needle outer packaging.\n\u2022 Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n\u2022 Twist to lock the needle to the luer container.\n\u2022 Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n\u2022 Remove excess gas from the syringe.\n\u2022 Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle \u2018bevel up\u2019 position is\norientated to the lever arm (Figure 3).\n\u2022 Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n\u2022 Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n\u2022 If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n\u2022 Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex\u00ae treatment groups,\nregardless of the investigator\u2019s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex\u00ae and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex\u00ae If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher\u2019s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_60", + "extensionAttributes": [], + "name": "NCI_9", + "text": "

See section 9 Statistical Considerations.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_61", + "extensionAttributes": [], + "name": "NCI_9_1", + "text": "

See section 9.1 Primary Endpoint Analysis.

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\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
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\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
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\n

10 Adverse Event Reporting

\n
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\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator\u2019s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n\u2022

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

\u2022

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

\u2022

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

\u2022

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

\u2022

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories \u2018Definite\u2019, \u2018probable\u2019 and \u2018possible\u2019 are considered study drug related.\nCategories \u2018not likely\u2019 and \u2018not related\u2019 are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
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\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
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\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n\u2022

\n

results in death,

\n

\u2022

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

\u2022

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

\u2022

\n

results in persistent or significant disability/incapacity,

\n

\u2022

\n

is a congenital anomaly/birth defect,

\n

\u2022

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
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\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator\u2019s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM \u2013 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE\u2019s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_69", + "extensionAttributes": [], + "name": "NCI_10_3", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_70", + "extensionAttributes": [], + "name": "NCI_11", + "text": "
\n

11 Administrative

\n
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\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_72", + "extensionAttributes": [], + "name": "NCI_11_2", + "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_73", + "extensionAttributes": [], + "name": "NCI_11_3", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_74", + "extensionAttributes": [], + "name": "NCI_11_4", + "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_75", + "extensionAttributes": [], + "name": "NCI_11_5", + "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_76", + "extensionAttributes": [], + "name": "NCI_11_6", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
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\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
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\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n\u2022\n\u2022\n\u2022

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_79", + "extensionAttributes": [], + "name": "NCI_12", + "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n\u00b0C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

\u00b5M\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

\u00b5g

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_80", + "extensionAttributes": [], + "name": "NCI_13", + "text": "
\n

13 Appendix A: Eligibility Checklist\n\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n\u2264 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) \u2265 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) \u2265 1.5 x 10 /L and platelet count \u2265 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin \u2265 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin \u2264 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine \u2264 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin \u2265 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND Fasting Triglycerides \u2264 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR \u2264 1.5. (Anticoagulation is allowed if target INR \u2264 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n\u2265 20 mm by chest x-ray, as \u2265 10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n\u2022 Bisphosphonates, Zometa or Xgeva for bone metastases\n\u2022 Hormonal therapy (e.g., AI, Tamoxifen)\n\u2022 a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient\u2019s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_81", + "extensionAttributes": [], + "name": "NCI_14", + "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_82", + "extensionAttributes": [], + "name": "NCI_15", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John\u2019s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John\u2019s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John\u2019s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA\u2019s\n\u201cGuidance for Industry, Drug Interaction Studies\u201d, the University of Washington\u2019s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_83", + "extensionAttributes": [], + "name": "NCI_16", + "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient\u2019s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
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17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

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18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
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\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex\u00ae) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO\u2019Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses\u2019 Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator\u2019s Statement\n1.

\n

I have carefully read this protocol entitled \u201cRandomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014\u201d (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
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See section 20 Investigator's Statement.

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Medications that can Inhibit/Induce CYP3A4 and PgP", + "displaySectionNumber": true, + "displaySectionTitle": true, + "childIds": [], + "previousId": "NarrativeContent_81", + "nextId": "NarrativeContent_83", + "contentItemId": "NarrativeContentItem_82", + "instanceType": "NarrativeContent" + }, + { + "id": "NarrativeContent_83", + "extensionAttributes": [], + "name": "NC_16", + "sectionNumber": "16", + "sectionTitle": "Appendix D: New York Heart Association (NYHA) Cardiac Classification", + "displaySectionNumber": true, + "displaySectionTitle": true, + "childIds": [], + "previousId": "NarrativeContent_82", + "nextId": "NarrativeContent_84", + "contentItemId": "NarrativeContentItem_83", + "instanceType": "NarrativeContent" + }, + { + "id": "NarrativeContent_84", + "extensionAttributes": [], + "name": "NC_17", + "sectionNumber": "17", + "sectionTitle": "Appendix E: CTEP Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0", + "displaySectionNumber": true, + 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"extensionAttributes": [], + "name": "NCI_1", + "text": "

See section 1 Introduction.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_2", + "extensionAttributes": [], + "name": "NCI_1_1", + "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor α activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell’s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole ≥ 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_3", + "extensionAttributes": [], + "name": "NCI_1_2", + "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_4", + "extensionAttributes": [], + "name": "NCI_1_3", + "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_5", + "extensionAttributes": [], + "name": "NCI_1_3_1", + "text": "
\n

Fulvestrant (Faslodex®, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex®\n(fulvestrant) Injection for “…the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy”.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_6", + "extensionAttributes": [], + "name": "NCI_1_3_2", + "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_7", + "extensionAttributes": [], + "name": "NCI_1_3_3", + "text": "
\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_8", + "extensionAttributes": [], + "name": "NCI_1_4", + "text": "
\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican®) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress®) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor® and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor® received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia® in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor® was\napproved for “progressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease” in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor® received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor® received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n•

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

•

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_9", + "extensionAttributes": [], + "name": "NCI_1_4_1", + "text": "
\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n•\n•\n•

\n

•\n•

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n•

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

•

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 μM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or ‘resistant’ (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_10", + "extensionAttributes": [], + "name": "NCI_1_4_2", + "text": "
\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator’s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-τ is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-τ and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator’s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator’s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican®, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress®) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator’s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor® for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n•\n•\n•\n•

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor®) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence ≥ 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence ≥\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence ≥ 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator’s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_11", + "extensionAttributes": [], + "name": "NCI_1_4_3", + "text": "

See section 1.4.3 Clinical Experience.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_12", + "extensionAttributes": [], + "name": "NCI_1_5", + "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_13", + "extensionAttributes": [], + "name": "NCI_2", + "text": "

See section 2 Objectives.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_14", + "extensionAttributes": [], + "name": "NCI_2_1", + "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_15", + "extensionAttributes": [], + "name": "NCI_2_2", + "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_16", + "extensionAttributes": [], + "name": "NCI_3", + "text": "

See section 3 Selection of Patients.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_17", + "extensionAttributes": [], + "name": "NCI_3_1", + "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n•\n•

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n•

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n•\n•\n•\n•

\n

•

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage ≥ 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n•\n•\n•\n•\n•\n•\n•

\n

•

\n

total white blood cell count (leukocytes, WBC) ≥ 3.0 x 109/L, absolute\nneutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L\nhemoglobin ≥ 9 g/dL\nserum bilirubin ≤ 1.5 x ULN\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\nserum creatinine ≤ 1.5 x ULN\nserum albumin ≥ 3 g/dL\nfasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting\ntriglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR ≤ 1.5 (Anticoagulation is allowed if target INR ≤ 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin ≤ 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as ≥ 20 mm by chest x-ray, as ≥\n10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n•

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

•

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

•

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient’s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_18", + "extensionAttributes": [], + "name": "NCI_4", + "text": "

See section 4 Randomization Procedures.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_19", + "extensionAttributes": [], + "name": "NCI_4_1", + "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_20", + "extensionAttributes": [], + "name": "NCI_4_2", + "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_21", + "extensionAttributes": [], + "name": "NCI_4_3", + "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin ≤ 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_22", + "extensionAttributes": [], + "name": "NCI_5", + "text": "

See section 5 Treatment Plan.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_23", + "extensionAttributes": [], + "name": "NCI_5_1", + "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_24", + "extensionAttributes": [], + "name": "NCI_5_2", + "text": "

See section 5.2 Dosing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_25", + "extensionAttributes": [], + "name": "NCI_5_2_1", + "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_26", + "extensionAttributes": [], + "name": "NCI_5_2_2", + "text": "
\n

•

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

•

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

•

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

•

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

•

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

•

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

•

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_27", + "extensionAttributes": [], + "name": "NCI_5_3", + "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_28", + "extensionAttributes": [], + "name": "NCI_5_3_1", + "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n•

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

•

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is ≤ 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

•

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

•

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

•

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

•

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nIf resolution occurs within ≤ 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade ≤ 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, ≥ 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade ≤1

\n

(platelets <50, ≥ 25 x 10 /L)

\n

If resolution occurs ≤ 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, ≥ 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade ≤ 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade ≤1 or baseline\nvalue\nIf AE resolution occurs ≤ 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade ≤ 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade ≤ 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_29", + "extensionAttributes": [], + "name": "NCI_5_3_2", + "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for ≥ 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence ≥ 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence ≥ 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator’s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

≤ baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n≤ baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n•

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

•

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered ‘cured’).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n˃2 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed “miracle mouth wash’’ QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using “miracle mouthwash’’.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and “miracle mouth wash”.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and “miracle mouth wash”\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase®) or Periogard® oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol–containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to ≤ grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade ≤\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to ≤ grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade ≤ 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to ≤\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_30", + "extensionAttributes": [], + "name": "NCI_5_3_3", + "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken ≤ 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_31", + "extensionAttributes": [], + "name": "NCI_5_3_4", + "text": "
\n

The following restrictions apply during the entire duration of the study:\n•

\n

No other investigational therapy should be given to patients.

\n

•

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

•

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

•

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

•

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

•

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

•

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

•

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

•

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

•

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John’s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week’s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient’s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_32", + "extensionAttributes": [], + "name": "NCI_5_3_5", + "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_33", + "extensionAttributes": [], + "name": "NCI_5_4", + "text": "

See section 5.4 Supportive Care.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_34", + "extensionAttributes": [], + "name": "NCI_5_5", + "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to ≤ grade 1 (or if >grade 1, event must be permanent and stable).

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_35", + "extensionAttributes": [], + "name": "NCI_5_6", + "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n•

\n

Withdrawal of the patient’s consent (patient’s decision to withdraw for any reason)

\n

•

\n

Termination of the study by PrECOG

\n

•

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

•

\n

Inability to comply with protocol

\n

•

\n

Discretion of the investigator

\n

•

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_36", + "extensionAttributes": [], + "name": "NCI_6", + "text": "

See section 6 Measurement of Effect.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_37", + "extensionAttributes": [], + "name": "NCI_6_1", + "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_38", + "extensionAttributes": [], + "name": "NCI_6_1_1", + "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_39", + "extensionAttributes": [], + "name": "NCI_6_1_2", + "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n•

\n

≥ 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

•

\n

≥ 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

•

\n

≥ 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be ≥ 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with ≥ 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n‘Cystic lesions’ thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_40", + "extensionAttributes": [], + "name": "NCI_6_1_3", + "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and ≥ 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n•\n•

\n

•

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest “increase” in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from “trace” to\n“large”, an increase in nodal disease from “localized” to “widespread”, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of “non-target” lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient’s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n“symptomatic deterioration”. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*‘Non-CR/Non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_41", + "extensionAttributes": [], + "name": "NCI_6_1_4", + "text": "

See section 6.1.4 Response Criteria.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_42", + "extensionAttributes": [], + "name": "NCI_6_1_5", + "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_43", + "extensionAttributes": [], + "name": "NCI_6_1_6", + "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

£

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

£

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: ≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: ≤ 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNAPCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n£ Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_44", + "extensionAttributes": [], + "name": "NCI_7", + "text": "

See section 7 Study Parameters.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_45", + "extensionAttributes": [], + "name": "NCI_7_1", + "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_46", + "extensionAttributes": [], + "name": "NCI_7_1_1", + "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin ≤ 4 weeks of randomization to protocol therapy:\n•

\n

Medical history

\n

•

\n

Assessment of baseline signs and symptoms

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

•

\n

PT with INR

\n

•

\n

Urinalysis

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n• known or suspected past hepatitis B infection\n• blood transfusion(s) prior to 1990\n• current or prior IV drug users\n• current or prior dialysis\n• household contact with hepatitis B infected patient(s)\n• current or prior high-risk sexual activity\n• body piercing or tattoos\n• mother known to have hepatitis B\n• history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon ‘curative’ treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_47", + "extensionAttributes": [], + "name": "NCI_7_1_2", + "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within ≤ 7 days of Cycle 1 Day 1.

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

•

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

•

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_48", + "extensionAttributes": [], + "name": "NCI_7_1_3", + "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to ≤ grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

•

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_49", + "extensionAttributes": [], + "name": "NCI_7_1_4", + "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until ≤ grade 1\nor if the grade is >1, the event must be permanent and stable.\n•

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

•

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

•

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n•

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_50", + "extensionAttributes": [], + "name": "NCI_7_1_5", + "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until ≤ grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_51", + "extensionAttributes": [], + "name": "NCI_8", + "text": "

See section 8 Drug Formulation and Procurement.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_52", + "extensionAttributes": [], + "name": "NCI_8_1", + "text": "

See section 8.1 Everolimus.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_53", + "extensionAttributes": [], + "name": "NCI_8_1_1", + "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_54", + "extensionAttributes": [], + "name": "NCI_8_1_2", + "text": "
\n

Everolimus should be stored at room temperature between 20°C to 25°C (68°F to 77°F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n•

\n

Everolimus/placebo dose may be taken with or without food.

\n

•

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

•

\n

Vomited doses should not be replaced.

\n

•

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n•\n•\n•\n•\n•

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_55", + "extensionAttributes": [], + "name": "NCI_8_1_3", + "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_56", + "extensionAttributes": [], + "name": "NCI_8_1_4", + "text": "
\n

The most common adverse reactions (incidence ≥ 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence ≥ 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_57", + "extensionAttributes": [], + "name": "NCI_8_1_5", + "text": "
\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n•

\n

Amount received and placed in storage area.

\n

•

\n

Amount currently in storage area.

\n

•

\n

Label ID number or batch number.

\n

•

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

•

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

•

\n

Amount transferred to another area for dispensing or storage.

\n

•

\n

Non-study disposition (e.g., wasted, broken).

\n

•

\n

Amount returned to manufacturer, if applicable

\n

•

\n

Amount destroyed at study site, if applicable

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_58", + "extensionAttributes": [], + "name": "NCI_8_1_6", + "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site’s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_59", + "extensionAttributes": [], + "name": "NCI_8_2", + "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide™) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2°-8°C (36°-46°F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex® Package Insert 1621903 Rev 12/11)\n• Remove the glass syringe barrel from tray and check that it is not damaged\n• Remove perforated patient record label from syringe\n• Peel open the safety needle outer packaging.\n• Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n• Twist to lock the needle to the luer container.\n• Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n• Remove excess gas from the syringe.\n• Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle ‘bevel up’ position is\norientated to the lever arm (Figure 3).\n• Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n• Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n• If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n• Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex® treatment groups,\nregardless of the investigator’s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex® and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex® If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher’s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_60", + "extensionAttributes": [], + "name": "NCI_9", + "text": "

See section 9 Statistical Considerations.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_61", + "extensionAttributes": [], + "name": "NCI_9_1", + "text": "

See section 9.1 Primary Endpoint Analysis.

", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_62", + "extensionAttributes": [], + "name": "NCI_9_2", + "text": "
\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_63", + "extensionAttributes": [], + "name": "NCI_9_3", + "text": "
\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
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\n

10 Adverse Event Reporting

\n
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\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator’s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n•

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

•

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

•

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

•

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

•

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories ‘Definite’, ‘probable’ and ‘possible’ are considered study drug related.\nCategories ‘not likely’ and ‘not related’ are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until ≤\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
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\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
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\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n•

\n

results in death,

\n

•

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

•

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

•

\n

results in persistent or significant disability/incapacity,

\n

•

\n

is a congenital anomaly/birth defect,

\n

•

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
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\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator’s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM – 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE’s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_69", + "extensionAttributes": [], + "name": "NCI_10_3", + "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
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\n

11 Administrative

\n
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\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
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\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_73", + "extensionAttributes": [], + "name": "NCI_11_3", + "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
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\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
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\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_76", + "extensionAttributes": [], + "name": "NCI_11_6", + "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
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\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
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\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n•\n•\n•

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
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\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n°C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

µM\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

µg

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
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\n

13 Appendix A: Eligibility Checklist\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n≤ 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) ≥ 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) ≥ 1.5 x 10 /L and platelet count ≥ 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin ≥ 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin ≤ 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine ≤ 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin ≥ 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND Fasting Triglycerides ≤ 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR ≤ 1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n≥ 20 mm by chest x-ray, as ≥ 10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n• Bisphosphonates, Zometa or Xgeva for bone metastases\n• Hormonal therapy (e.g., AI, Tamoxifen)\n• a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient’s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
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\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_82", + "extensionAttributes": [], + "name": "NCI_15", + "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John’s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John’s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John’s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA’s\n“Guidance for Industry, Drug Interaction Studies”, the University of Washington’s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
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\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient’s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
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\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
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\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
", + "instanceType": "NarrativeContentItem" + }, + { + "id": "NarrativeContentItem_86", + "extensionAttributes": [], + "name": "NCI_19", + "text": "
\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

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17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex®) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

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30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO’Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

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45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses’ Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator’s Statement\n1.

\n

I have carefully read this protocol entitled “Randomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014” (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
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{ + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_11", + "name": "Education Level", + "label": "Education Level", + "aliases": [ + "EDULEVEL", + "Education", + "Education Level", + "Education Level Completed", + "education_level", + "Educational Attainment", + "Educational Level", + "Level of Education Attained" + ], + "href": "/mdr/bc/biomedicalconcepts/C17953", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C17953", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Education Level" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_12", + "name": "Number of Years of Education", + "label": "Number of Years of Education", + "aliases": [ + "EDUYRNUM", + "Number of Years of Education" + ], + "href": "/mdr/bc/biomedicalconcepts/C122393", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C122393", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Number of Years of Education" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_14", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "aliases": [ + "Medical History", + "Medical History Collection" + ], + "href": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_35", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_36", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ 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"CONCPROP.BiomedicalConceptProperty_39", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + 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"decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", 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"CONCPROP.BiomedicalConceptProperty_802", + "name": "AESOD", + "label": "AESOD", + "mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C179175", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_136", + "name": "Complete", + "label": "Complete", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C25250", + "properties": [], + "coding": [ + { + "code": "C25250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Complete [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_137", + "name": "Failure To Meet Continuation Criteria", + "label": "Failure To Meet Continuation Criteria", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C139236", + "properties": [], + "coding": [ + { + "code": "C139236", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Failure To Meet Continuation Criteria [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_138", + "name": "Dead", + "label": "Dead", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C28554", + "properties": [], + "coding": [ + { + "code": "C28554", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Dead [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_139", + "name": "Lack of Efficacy", + "label": "Lack of Efficacy", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48226", + "properties": [], + "coding": [ + { + "code": "C48226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lack of Efficacy [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_140", + "name": "Lost To Follow-Up", + "label": "Lost To Follow-Up", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48227", + "properties": [], + "coding": [ + { + "code": "C48227", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lost To Follow-Up [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_141", + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "coding": [ + { + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_142", + "name": "Physician Decision", + "label": "Physician Decision", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48250", + "properties": [], + "coding": [ + { + "code": "C48250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Physician Decision [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_143", + "name": "Pregnant Subject", + "label": "Pregnant Subject", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C191656", + "properties": [], + "coding": [ + { + "code": "C191656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Pregnant Subject [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_144", + "name": "Progressive Disease", + "label": "Progressive Disease", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C35571", + "properties": [], + "coding": [ + { + "code": "C35571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Progressive Disease [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_145", + "name": "Protocol Deviation", + "label": "Protocol Deviation", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C50996", + "properties": [], + "coding": [ + { + "code": "C50996", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Protocol Deviation" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_146", + "name": "Study Site Transfer", + "label": "Study Site Transfer", + "aliases": [ + "Site Transfer", + "Study Subject Site Transfer" + ], + "href": "/mdr/bc/biomedicalconcepts/C186208", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.d8fccc32" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Site Transfer" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_147", + "name": "Study Terminated By Sponsor", + "label": "Study Terminated By Sponsor", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49632", + "properties": [], + "coding": [ + { + "code": "C49632", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Terminated By Sponsor" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_148", + "name": "Subject Removed at Sponsor Request", + "label": "Subject Removed at Sponsor Request", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C161410", + "properties": [], + "coding": [ + { + "code": "C161410", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Subject Removed at Sponsor Request [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_149", + "name": "Trial Screen Failure", + "label": "Trial Screen Failure", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49628", + "properties": [], + "coding": [ + { + "code": "C49628", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Screen Failure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_150", + "name": "Trial Site 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"CONCPROP.BiomedicalConceptProperty_823", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a3e2e2db" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Withdrawal of Consent From Protocol-Specified Activity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_153", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, 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"code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_154", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "aliases": [ + "DIABP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": 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"codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25299", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_155", + "name": "Heart Rate", + "label": "Heart Rate", + "aliases": [ + "HR" + ], + "href": "/mdr/bc/biomedicalconcepts/C49677", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_880", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_881", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.20024ecd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_882", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_156", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_887", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": 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"codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "SUDUR", + "label": "SUDUR", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.30a86bdd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "PRLAT", + "label": "PRLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.39e500d6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ 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"CONCPROP.BiomedicalConceptProperty_98", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_100", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_101", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_102", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C168688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Height" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_103", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_104", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.6751dc8e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.5ae118a0" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.35f151cb" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + 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"OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": 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"codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_741", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_742", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_748", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_749", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_750", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_777", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_778", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_779", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_780", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_781", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_782", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_783", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_784", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_785", + "name": "AETERM", + "label": "AETERM", + "mandatory": true, + "coding": [ + { + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Verbatim Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_786", + "name": "AEDECOD", + "label": "AEDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_787", + "name": "AELOC", + "label": "AELOC", + "mandatory": false, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_788", + "name": "AESEV", + "label": "AESEV", + "mandatory": false, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_789", + "name": "AESER", + "label": "AESER", + "mandatory": false, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Seriousness of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_790", + "name": "AEACN", + "label": "AEACN", + "mandatory": false, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_791", + "name": "AEACNOTH", + "label": "AEACNOTH", + "mandatory": false, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_792", + "name": "AEREL", + "label": "AEREL", + "mandatory": false, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_793", + "name": "AERELNST", + "label": "AERELNST", + "mandatory": false, + "coding": [ + { + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_794", + "name": "AEPATT", + "label": "AEPATT", + "mandatory": false, + "coding": [ + { + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Pattern" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_795", + "name": "AEOUT", + "label": "AEOUT", + "mandatory": false, + "coding": [ + { + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Outcome" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_796", + "name": "AESCAN", + "label": "AESCAN", + "mandatory": false, + "coding": [ + { + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Involves Cancer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_797", + "name": "AESCONG", + "label": "AESCONG", + "mandatory": false, + "coding": [ + { + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_798", + "name": "AESDISAB", + "label": "AESDISAB", + "mandatory": false, + "coding": [ + { + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Disabling Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_799", + "name": "AESDTH", + "label": "AESDTH", + "mandatory": false, + "coding": [ + { + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Death Related to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_800", + "name": "AESHOSP", + "label": "AESHOSP", + "mandatory": false, + "coding": [ + { + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_801", + "name": "AESLIFE", + "label": "AESLIFE", + "mandatory": false, + "coding": [ + { + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Life Threatening Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_802", + "name": "AESOD", + "label": "AESOD", + "mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.d8fccc32" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_823", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a3e2e2db" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_835", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_836", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_837", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_864", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_865", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_866", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_867", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_880", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_881", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.20024ecd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_882", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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+ { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C83217", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Birth Date and Time" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_10", + "name": "Sex", + "label": null, + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C28421", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_24", + "name": "SEX", + "label": "SEX", + "mandatory": false, + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_25", + "name": "DMDTC", + "label": "DMDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C28421", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-04-01", + "decode": "Sex" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_11", + "name": "Education Level", + "label": "Education Level", + "aliases": [ + "EDULEVEL", + "Education", + "Education Level", + "Education Level Completed", + "education_level", + "Educational Attainment", + "Educational Level", + "Level of Education Attained" + ], + "href": "/mdr/bc/biomedicalconcepts/C17953", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_26", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_27", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C17953", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Education Level" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_12", + "name": "Number of Years of Education", + "label": "Number of Years of Education", + "aliases": [ + "EDUYRNUM", + "Number of Years of Education" + ], + "href": "/mdr/bc/biomedicalconcepts/C122393", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_28", + "name": "SCORRES", + "label": "SCORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_29", + "name": "SCDTC", + "label": "SCDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C122393", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Number of Years of Education" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_14", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "aliases": [ + "Medical History", + "Medical History Collection" + ], + "href": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_30", + "name": "MHTERM", + "label": "MHTERM", + "mandatory": true, + "coding": [ + { + "code": "C83118", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_31", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83346", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_32", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83338", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_33", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83330", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_34", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to 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"/mdr/bc/biomedicalconcepts/C81229", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_37", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_38", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_39", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + 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"decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C201990", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Caffeine Use History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_17", + "name": "History of Tobacco Use", + "label": "History of Tobacco Use", + "aliases": [ + "Tobacco Use", + "Tobacco Use History" + ], + "href": "/mdr/bc/biomedicalconcepts/C181760", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": 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"mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C179175", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_136", + "name": "Complete", + "label": "Complete", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C25250", + "properties": [], + "coding": [ + { + "code": "C25250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Complete [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_137", + "name": "Failure To Meet Continuation Criteria", + "label": "Failure To Meet Continuation Criteria", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C139236", + "properties": [], + "coding": [ + { + "code": "C139236", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Failure To Meet Continuation Criteria [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_138", + "name": "Dead", + "label": "Dead", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C28554", + "properties": [], + "coding": [ + { + "code": "C28554", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Dead [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_139", + "name": "Lack of Efficacy", + "label": "Lack of Efficacy", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48226", + "properties": [], + "coding": [ + { + "code": "C48226", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lack of Efficacy [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_140", + "name": "Lost To Follow-Up", + "label": "Lost To Follow-Up", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48227", + "properties": [], + "coding": [ + { + "code": "C48227", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Lost To Follow-Up [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_141", + "name": "Adverse Event [RETIRED]", + "label": "Adverse Event [RETIRED]", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C41331", + "properties": [], + "coding": [ + { + "code": "C41331", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Adverse Event [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_142", + "name": "Physician Decision", + "label": "Physician Decision", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C48250", + "properties": [], + "coding": [ + { + "code": "C48250", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Physician Decision [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_143", + "name": "Pregnant Subject", + "label": "Pregnant Subject", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C191656", + "properties": [], + "coding": [ + { + "code": "C191656", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Pregnant Subject [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_144", + "name": "Progressive Disease", + "label": "Progressive Disease", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C35571", + "properties": [], + "coding": [ + { + "code": "C35571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Progressive Disease [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_145", + "name": "Protocol Deviation", + "label": "Protocol Deviation", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C50996", + "properties": [], + "coding": [ + { + "code": "C50996", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Protocol Deviation" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_146", + "name": "Study Site Transfer", + "label": "Study Site Transfer", + "aliases": [ + "Site Transfer", + "Study Subject Site Transfer" + ], + "href": "/mdr/bc/biomedicalconcepts/C186208", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.d8fccc32" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C186208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Site Transfer" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_147", + "name": "Study Terminated By Sponsor", + "label": "Study Terminated By Sponsor", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49632", + "properties": [], + "coding": [ + { + "code": "C49632", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Study Terminated By Sponsor" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_148", + "name": "Subject Removed at Sponsor Request", + "label": "Subject Removed at Sponsor Request", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C161410", + "properties": [], + "coding": [ + { + "code": "C161410", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Subject Removed at Sponsor Request [RETIRED]" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_149", + "name": "Trial Screen Failure", + "label": "Trial Screen Failure", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C49628", + "properties": [], + "coding": [ + { + "code": "C49628", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Trial Screen Failure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_150", + "name": "Trial Site Terminated by Sponsor", + "label": "Trial 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"label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a3e2e2db" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C170610", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Withdrawal of Consent From Protocol-Specified Activity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_153", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_835", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_836", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_837", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C25298", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_154", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "aliases": [ + "DIABP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25299", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_864", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_865", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_866", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_867", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date 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"CONCPROP.BiomedicalConceptProperty_882", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C49677", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Heart Rate" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_156", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_887", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of 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"codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_40", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_41", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_42", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_43", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_44", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_45", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_46", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_47", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_48", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_49", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_50", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_51", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_52", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_53", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_54", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_55", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_56", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_57", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_58", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_59", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_60", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_61", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_62", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_63", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_64", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_65", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_66", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_67", + "name": "SUTRT", + "label": "SUTRT", + "mandatory": true, + "coding": [ + { + "code": "C83092", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Reported Name" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_68", + "name": "SUPRESP", + "label": "SUPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_69", + "name": "SUOCCUR", + "label": "SUOCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_70", + "name": "SUDOSE", + "label": "SUDOSE", + "mandatory": false, + "coding": [ + { + "code": "C83416", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_71", + "name": "SUDOSTXT", + "label": "SUDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83041", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_72", + "name": "SUDOSU", + "label": "SUDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83038", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_73", + "name": "SUDOSFRQ", + "label": "SUDOSFRQ", + "mandatory": false, + "coding": [ + { + "code": "C83044", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Dose Frequency" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_74", + "name": "SUSTDTC", + "label": "SUSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83431", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_75", + "name": "SUENDTC", + "label": "SUENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_76", + "name": "SUDUR", + "label": "SUDUR", + "mandatory": false, + "coding": [ + { + "code": "C83419", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Substance Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_77", + "name": "SUSTRF", + "label": "SUSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_78", + "name": "SUSTRTPT", + "label": "SUSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_79", + "name": "SUSTTPT", + "label": "SUSTTPT", + "mandatory": false, + "coding": [ + { + "code": "C82575", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_80", + "name": "SUENRF", + "label": "SUENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_81", + "name": "SUENRTPT", + "label": "SUENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_82", + "name": "SUENTPT", + "label": "SUENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_83", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_84", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.30a86bdd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_85", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_86", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_87", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_88", + "name": "PRLAT", + "label": "PRLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_89", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_90", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_91", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.39e500d6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_92", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_93", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_94", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ 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"CONCPROP.BiomedicalConceptProperty_98", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_99", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_100", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_101", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_102", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C168688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Height" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_103", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_104", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_249", + "name": "EGDTC", + "label": "EGDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.6751dc8e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Anatomic Site" + } + ], + "codeList": "CL.5ae118a0" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "PRSTDTC", + "label": "PRSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C117529", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Start Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "PRENDTC", + "label": "PRENDTC", + "mandatory": false, + "coding": [ + { + "code": "C117530", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "End Date and Time of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "PRTRT", + "label": "PRTRT", + "mandatory": true, + "coding": [ + { + "code": "C117511", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Reported Name of Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "PRDECOD", + "label": "PRDECOD", + "mandatory": true, + "coding": [ + { + "code": "C117512", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Standardized Name of Procedure" + } + ], + "codeList": "CL.35f151cb" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "PRPRESP", + "label": "PRPRESP", + "mandatory": false, + "coding": [ + { + "code": "C171000", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Prespecified Event or Intervention Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "PROCCUR", + "label": "PROCCUR", + "mandatory": false, + "coding": [ + { + "code": "C127786", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Occurrence Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "PRLOC", + "label": "PRLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-12-16", + "decode": "Anatomic Site" + 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"OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "CMDECOD", + "label": "CMDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83345", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "CMCLAS", + "label": "CMCLAS", + "mandatory": 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"codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "CMENRTPT", + "label": "CMENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "CMENTPT", + "label": "CMENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_741", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_742", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_748", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_749", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_750", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_777", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_778", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_779", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_780", + "name": "QSORRES", + "label": "QSORRES", + "mandatory": false, + "coding": [ + { + "code": "C46126", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Ordinal Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_781", + "name": "QSDTC", + "label": "QSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_782", + "name": "QSEVAL", + "label": "QSEVAL", + "mandatory": false, + "coding": [ + { + "code": "C51824", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator" + } + ], + "codeList": "CL.b8dca4b6" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_783", + "name": "Adverse Event Yes No Indicator", + "label": "Adverse Event Yes No Indicator", + "mandatory": true, + "coding": [ + { + "code": "C83347", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Yes No Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_784", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_785", + "name": "AETERM", + "label": "AETERM", + "mandatory": true, + "coding": [ + { + "code": "C78541", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Verbatim Description" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_786", + "name": "AEDECOD", + "label": "AEDECOD", + "mandatory": false, + "coding": [ + { + "code": "C83344", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_787", + "name": "AELOC", + "label": "AELOC", + "mandatory": false, + "coding": [ + { + "code": "C83205", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_788", + "name": "AESEV", + "label": "AESEV", + "mandatory": false, + "coding": [ + { + "code": "C53253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Severity of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_789", + "name": "AESER", + "label": "AESER", + "mandatory": false, + "coding": [ + { + "code": "C53252", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Seriousness of Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_790", + "name": "AEACN", + "label": "AEACN", + "mandatory": false, + "coding": [ + { + "code": "C83013", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_791", + "name": "AEACNOTH", + "label": "AEACNOTH", + "mandatory": false, + "coding": [ + { + "code": "C83109", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_792", + "name": "AEREL", + "label": "AEREL", + "mandatory": false, + "coding": [ + { + "code": "C41358", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_793", + "name": "AERELNST", + "label": "AERELNST", + "mandatory": false, + "coding": [ + { + "code": "C83210", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_794", + "name": "AEPATT", + "label": "AEPATT", + "mandatory": false, + "coding": [ + { + "code": "C83208", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Pattern" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_795", + "name": "AEOUT", + "label": "AEOUT", + "mandatory": false, + "coding": [ + { + "code": "C49489", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Outcome" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_796", + "name": "AESCAN", + "label": "AESCAN", + "mandatory": false, + "coding": [ + { + "code": "C83211", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Involves Cancer" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_797", + "name": "AESCONG", + "label": "AESCONG", + "mandatory": false, + "coding": [ + { + "code": "C83117", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_798", + "name": "AESDISAB", + "label": "AESDISAB", + "mandatory": false, + "coding": [ + { + "code": "C113380", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Disabling Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_799", + "name": "AESDTH", + "label": "AESDTH", + "mandatory": false, + "coding": [ + { + "code": "C48275", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Death Related to Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_800", + "name": "AESHOSP", + "label": "AESHOSP", + "mandatory": false, + "coding": [ + { + "code": "C83052", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_801", + "name": "AESLIFE", + "label": "AESLIFE", + "mandatory": false, + "coding": [ + { + "code": "C84266", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Life Threatening Adverse Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_802", + "name": "AESOD", + "label": "AESOD", + "mandatory": false, + "coding": [ + { + "code": "C83214", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_803", + "name": "AESMIE", + "label": "AESMIE", + "mandatory": false, + "coding": [ + { + "code": "C83053", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_804", + "name": "AECONTRT", + "label": "AECONTRT", + "mandatory": false, + "coding": [ + { + "code": "C83199", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_805", + "name": "AETOXGR", + "label": "AETOXGR", + "mandatory": false, + "coding": [ + { + "code": "C78605", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_806", + "name": "AESTDTC", + "label": "AESTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83215", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_807", + "name": "AEENDTC", + "label": "AEENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83201", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Adverse Event End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_808", + "name": "AEENRF", + "label": "AEENRF", + "mandatory": false, + "coding": [ + { + "code": "C82557", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_809", + "name": "AEENRTPT", + "label": "AEENRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82558", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_810", + "name": "AEENTPT", + "label": "AEENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_811", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.d8fccc32" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_812", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_813", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_823", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, + "coding": [ + { + "code": "C82977", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" + } + ], + "codeList": "CL.a3e2e2db" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_824", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, + "coding": [ + { + "code": "C82571", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_825", + "name": "DSSTDTC", + "label": "DSSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C82517", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_832", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_833", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_834", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_835", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_836", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_837", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_862", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_863", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C49669", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_864", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_865", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_866", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_867", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_880", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_881", + "name": "VSORRESU", + "label": "VSORRESU", + "mandatory": false, + "coding": [ + { + "code": "C73688", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Count per Minute" + } + ], + "codeList": "CL.20024ecd" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_882", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_883", + "name": "VSLOC", + "label": "VSLOC", + "mandatory": false, + "coding": [ + { + "code": "C13717", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_884", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_885", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_886", + "name": "VSORRES", + "label": "VSORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": 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"decode": "After", + "instanceType": "Code" + }, + "value": "P2W", + "valueLabel": "2 Weeks", + "relativeToFrom": { + "id": "Code_53", + "extensionAttributes": [], + "code": "C201355", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-27", + "decode": "Start to Start", + "instanceType": "Code" + }, + "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", + "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", + "windowLower": null, + "windowUpper": null, + "windowLabel": null, + "instanceType": "Timing" + } + ], + "instances": [ + { + "id": "ScheduledActivityInstance_1", + "extensionAttributes": [], + "name": "SCREEN1", + "label": "Screen 1", + "description": "Screen 1 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_2", + "epochId": "StudyEpoch_1", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_1", + "Activity_2", + "Activity_3", + 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{ + "id": "ScheduledActivityInstance_5", + "extensionAttributes": [], + "name": "WEEK4", + "label": "Week 4", + "description": "Week 4 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_6", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_5" + }, + { + "id": "ScheduledActivityInstance_6", + "extensionAttributes": [], + "name": "WEEK6", + "label": "Week 6", + "description": "Week 6 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_7", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_17", + "Activity_22", + "Activity_23", + "Activity_24", + "Activity_26", + "Activity_28", + "Activity_33" + ], + "encounterId": "Encounter_6" + }, + { + "id": "ScheduledActivityInstance_7", + "extensionAttributes": [], + "name": "WEEK8", + "label": "Week 8", + "description": "Week 8 Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_8", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_31", + "Activity_31", + "Activity_32", + "Activity_32", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_7" + }, + { + "id": "ScheduledActivityInstance_8", + "extensionAttributes": [], + "name": "WEEK8N", + "label": "Week 8 NPI", + "description": "Week 8 NPI Activity Instance", + "defaultConditionId": "ScheduledActivityInstance_19", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_31", + "Activity_31", + "Activity_32", + "Activity_32", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_7" + }, + { + "id": "ScheduledActivityInstance_19", + "extensionAttributes": [], + "name": "WEEK12", + "label": "Week 12", + "description": "Week 12", + "defaultConditionId": "ScheduledActivityInstance_20", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + 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"extensionAttributes": [], + "name": "WEEK16", + "label": "Week 16", + "description": "Week 16", + "defaultConditionId": "ScheduledActivityInstance_22", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_22", + "extensionAttributes": [], + "name": "WEEK16N", + "label": "Week 16 NPI", + "description": "Week 16 NPI", + "defaultConditionId": "ScheduledActivityInstance_23", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_28", + "Activity_28", + "Activity_30", + "Activity_30", + "Activity_32", + "Activity_32", + "Activity_31", + "Activity_31", + "Activity_33", + "Activity_33" + ], + "encounterId": "Encounter_11" + }, + { + "id": "ScheduledActivityInstance_23", + "extensionAttributes": [], + "name": "WEEK20", + "label": "Week 20", + "description": "Week 20", + "defaultConditionId": "ScheduledActivityInstance_24", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_13" + }, + { + "id": "ScheduledActivityInstance_24", + "extensionAttributes": [], + "name": "WEEK20N", + "label": "Week 20 NPI", + "description": "Week 20 NPI", + "defaultConditionId": "ScheduledActivityInstance_25", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledActivityInstance", + "timelineId": null, + "timelineExitId": null, + "activityIds": [ + "Activity_33", + "Activity_33", + "Activity_14", + "Activity_14", + "Activity_17", + "Activity_17", + "Activity_22", + "Activity_22", + "Activity_23", + "Activity_23", + "Activity_24", + "Activity_24", + "Activity_26", + "Activity_26", + "Activity_28", + "Activity_28" + ], + "encounterId": "Encounter_13" + }, + { + "id": "ScheduledActivityInstance_25", + "extensionAttributes": [], + "name": "WEEK24", + "label": "Week 24", + "description": "Week 24", + "defaultConditionId": "ScheduledActivityInstance_26", + "epochId": "StudyEpoch_5", + "instanceType": 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"defaultConditionId": null, + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [ + { + "id": "Condition_1", + "extensionAttributes": [], + "condition": "is not null", + "conditionTargetId": "ScheduledActivityInstance_3", + "instanceType": "Condition" + } + ] + }, + { + "id": "ScheduledDecisionInstance_2", + "extensionAttributes": [], + "name": "test_2", + "label": "test_2", + "description": "test_2", + "defaultConditionId": "blahblahblah", + "epochId": "StudyEpoch_4", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + }, + { + "id": "ScheduledDecisionInstance_3", + "extensionAttributes": [], + "name": "test3", + "label": "test3", + "description": "test3", + "defaultConditionId": "ScheduledActivityInstance_11", + "epochId": "StudyEpoch_3", + "instanceType": "ScheduledDecisionInstance", + "conditionAssignments": [] + } + ], + "plannedDuration": null, + "instanceType": "ScheduleTimeline" + }, + { + "id": 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+ "bcSurrogates": [ + { + "id": "BiomedicalConceptSurrogate_9", + "extensionAttributes": [], + "name": "MHIS-NACC / MHIS01", + "label": "Modified Hachinski Ischemic Scale (C112523)", + "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_10", + "extensionAttributes": [], + "name": "MHIS0101", + "label": "Abrupt Onset (C112618)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_11", + "extensionAttributes": [], + "name": "MHIS0102", + "label": "Stepwise Deterioration (C112619)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_12", + "extensionAttributes": [], + "name": "MHIS0103", + "label": "Emotional Incontinence (C112620)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_13", + "extensionAttributes": [], + "name": "MHIS0104", + "label": "History or Presence of Hypertension (C112621)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_14", + "extensionAttributes": [], + "name": "MHIS0105", + "label": "History of Stroke (C112622)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_15", + "extensionAttributes": [], + "name": "MHIS0106", + "label": "Focal Neurological Symptoms (C112623)", + "description": "MHIS-NACC - Focal Neurological Symptoms", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_16", + "extensionAttributes": [], + "name": "MHIS0107", + "label": "Focal Neurological Signs (C112624)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_17", + "extensionAttributes": [], + "name": "MHIS0108", + "label": "Somatic Complaints (C112813)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_18", + "extensionAttributes": [], + "name": "MHIS0109", + "label": "Total Score (C112625)", + "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_19", + "extensionAttributes": [], + "name": "APOE Gene", + "label": "APOE Gene (C84468)", + "description": "This gene is involved in lipid transport and metabolism.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_20", + "extensionAttributes": [], + "name": "Mini-Mental Status Exam", + "label": "Mini-Mental Status Exam (C74982)", + "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_21", + "extensionAttributes": [], + "name": "MMSE - Question 1", + "label": "MMSE - Question 1 (C100542)", + "description": "The Mini-Mental State Examination (MMSE) Question 1.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_22", + "extensionAttributes": [], + "name": "MMSE - Question 2", + "label": "MMSE - Question 2 (C100548)", + "description": "The Mini-Mental State Examination (MMSE) Question 2.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_23", + "extensionAttributes": [], + "name": "MMSE - Question 3", + "label": "MMSE - Question 3 (C100554)", + "description": "The Mini-Mental State Examination (MMSE) Question 3.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_24", + "extensionAttributes": [], + "name": "MMSE - Question 4", + "label": "MMSE - Question 4 (C100558)", + "description": "The Mini-Mental State Examination (MMSE) Question 4.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_25", + "extensionAttributes": [], + "name": "MMSE - Question 6", + "label": "MMSE - Question 6 (C100575)", + "description": "The Mini-Mental State Examination (MMSE) Question 6.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_26", + "extensionAttributes": [], + "name": "MMSE Functional Test Question", + "label": "MMSE Functional Test Question (C100118)", + "description": "A question associated with the MMSE functional test.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_27", + "extensionAttributes": [], + "name": "ADCS-CGIC", + "label": "ADCS-CGIC Questionnaire Question (C103490)", + "description": "A question associated with the ADCS-CGIC questionnaire.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_28", + "extensionAttributes": [], + "name": "DAD", + "label": "Disability Assessment for Dementia Questionnaire (C105165)", + "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_29", + "extensionAttributes": [], + "name": "NPI - NPI Total Distress Score", + "label": "NPI - NPI Total Distress Score (C112482)", + "description": "Neuropsychiatric Inventory - Sub-total of distress score.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_30", + "extensionAttributes": [], + "name": "NPI - Anxiety Severity", + "label": "NPI - Anxiety Severity (C103615)", + "description": "Neuropsychiatric Inventory - Severity of the anxiety.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_31", + "extensionAttributes": [], + "name": "NPI - Disinhibition Frequency", + "label": "NPI - Disinhibition Frequency (C103623)", + "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_32", + "extensionAttributes": [], + "name": "NPI - Disinhibition Severity", + "label": "NPI - Disinhibition Severity (C103624)", + "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_33", + "extensionAttributes": [], + "name": "NPI - Disinhibition Distress", + "label": "NPI - Disinhibition Distress (C103625)", + "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + }, + { + "id": "BiomedicalConceptSurrogate_34", + "extensionAttributes": [], + "name": "NPI - Disinhibition FxS Score", + "label": "NPI - Disinhibition FxS Score (C112476)", + "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", + "notes": [], + "instanceType": "BiomedicalConceptSurrogate" + } + ], + "bcCategories": [], + "eligibilityCriterionItems": [], + "narrativeContentItems": [], + "abbreviations": [], + "administrableProducts": [], + "medicalDevices": [], + "productOrganizationRoles": [], + "dictionaries": [], + "conditions": [], + "notes": [], + "instanceType": "StudyVersion" + } + ], + "documentedBy": [], + "instanceType": "Study" + }, + "usdmVersion": "4.0", + "systemName": "SOA Workbench", + "systemVersion": "pi-fix-bc-props-specs-in-usdm" +} diff --git a/pyproject.toml b/pyproject.toml index b6ad7d3..ab74fc7 100644 --- a/pyproject.toml +++ b/pyproject.toml @@ -23,7 +23,8 @@ dependencies = [ "python-multipart>=0.0.9", "jmespath>=1.1.0", "cdisc-library-client>=0.1.6", - "mcp>=1.0.0" + "mcp>=1.0.0", + "python-docx>=1.1.0" ] [project.optional-dependencies] diff --git a/schema/define.yaml b/schema/define.yaml new file mode 100644 index 0000000..508b60a --- /dev/null +++ b/schema/define.yaml @@ -0,0 +1,2562 @@ +id: https://cdisc.org/dds +name: Data-Definition-Specification +title: Data Definition Specification (DDS) +description: >- + Data model for supply and demand data contracts to complement CDISC USDM, ODM, and Dataset-JSON. + This LinkML version includes semantics to act as Rosetta Stone for SDMX, FHIR, OMOP, RDF, and CDISC. +license: MIT +prefixes: + linkml: https://w3id.org/linkml/ + skos: http://www.w3.org/2004/02/skos/core# + odm: https://cdisc.org/odm2/ + usdm: https://cdisc.org/usdm/ + sdtm: https://cdisc.org/cosmos/sdtm_v1.0# + fhir: http://hl7.org/fhir/ + NCIT: http://purl.obolibrary.org/obo/NCIT_ + omop: https://omop.org/omop-cdm/ + qb: http://purl.org/linked-data/cube# + sdmx: http://purl.org/linked-data/sdmx# + dprod: https://ekgf.github.io/dprod/ + prov: http://www.w3.org/ns/prov# + dcat: http://www.w3.org/ns/dcat# + osb: https://openstudybuilder.com/ + dcterms: http://purl.org/dc/terms/ + dds: https://cdisc.org/dds +default_prefix: dds +default_range: string + +imports: + - linkml:types + +classes: + IdentifiableElement: + abstract: true + mixins: + - Identifiable + - Labelled + + GovernedElement: + abstract: true + mixins: + - Identifiable + - Labelled + - Governed + + Identifiable: + description: >- + A mixin that provides slots for making an entity addressable within a study or context + mixin: true + attributes: + OID: + description: >- + Local identifier within this study/context. + Use CDISC OID format for regulatory submissions, + or simple strings for internal use. + identifier: true + required: false + range: string + uuid: + description: Universal unique identifier + range: string + + Governed: + description: >- + A mixin that provides slots for audit trail and standards governance, including mandatory status, comments, and attribution + mixin: true + attributes: + mandatory: + description: >- + Is this element required? + range: boolean + comments: + description: >- + Comment on the element, such as a rationale for its inclusion or exclusion + range: Comment + multivalued: true + inlined: false + siteOrSponsorComments: + description: >- + Comment on the element, such as a rationale for its inclusion or exclusion + range: SiteOrSponsorComment + multivalued: true + inlined: false + purpose: + description: Purpose or rationale for this data element + any_of: + - range: string + - range: TranslatedText + lastUpdated: + description: When the resource was last updated + range: datetime + owner: + description: Party responsible for this element + narrow_mappings: + - prov:wasAttributedTo + - prov:wasAssociatedBy + any_of: + - range: User + - range: Organization + - range: string + wasDerivedFrom: + description: >- + Reference to another item that this item implements or extends, e.g. a template Item definition. + exact_mappings: + - prov:wasDerivedFrom + any_of: + - range: Item + - range: ItemGroup + - range: MetaDataVersion + - range: CodeList + - range: ReifiedConcept + - range: ConceptProperty + - range: Condition + - range: Method + - range: NominalOccurrence + - range: Dataflow + - range: CubeComponent + - range: DataProduct + - range: ProvisionAgreement + + Labelled: + description: >- + A mixin that provides slots for detailing meanings and multilingual descriptions + mixin: true + attributes: + name: + description: Short name or identifier, used for field names + range: string + description: + description: Detailed description, shown in tooltips + any_of: + - range: string + - range: TranslatedText + coding: + description: Semantic tags for this element + range: Coding + multivalued: true + inlined: true + inlined_as_list: true + label: + description: Human-readable label, shown in UIs + any_of: + - range: string + - range: TranslatedText + exact_mappings: + - skos:prefLabel + aliases: + description: >- + Alternative name or identifier + any_of: + - range: string + - range: TranslatedText + multivalued: true + inlined: true + inlined_as_list: true + exact_mappings: + - skos:altLabel + + Formatted: + description: >- + A mixin that provides slots for reporting, exchange, or storage formatting + mixin: true + related_mappings: + - sdmx:Facet + - sdmx:Representation + attributes: + decimalDigits: + description: >- + For decimal values, the number of digits after the decimal point + range: integer + displayFormat: + description: >- + A display format for the item + range: string + significantDigits: + description: >- + For numeric values, the number of significant digits + range: integer + + Versioned: + description: >- + A mixin that provides version and connectivity information, including version numbers and resource references + mixin: true + attributes: + version: + description: >- + The version of the external resources + range: string + href: + description: Machine-readable instructions to obtain the resource e.g. FHIR path, URL + range: string + required: false + + IsProfile: + description: >- + A mixin that provides additional metadata for FHIR resources and Data Products, including profiles, security tags, and validity periods + mixin: true + mixins: + - Versioned + attributes: + profile: + description: Profiles this resource claims to conform to + range: string + multivalued: true + security: + description: Security tags applied to this resource + range: Coding + multivalued: true + inlined: true + inlined_as_list: true + authenticator: + description: Who/what authenticated the resource + any_of: + - range: User + - range: Organization + - range: string + required: false + validityPeriod: + description: Time period during which the resouce is valid + range: Timing + required: false + + IsODMItem: + mixin: true + description: >- + A mixin that provides additional attributes for CDISC Operational Data Model items, including roles, completion instructions, and implementation notes + attributes: + role: + description: >- + Identifies the role of the item within the containing context, taken from the roleCodeList + any_of: + - range: string + - range: TranslatedText + roleCodeList: + description: >- + Reference to the CodeList that defines the roles for this item + range: CodeList + hasNoData: + description: >- + True if this is a manifest and there is no data for this item + range: boolean + crfCompletionInstructions: + any_of: + - range: string + - range: TranslatedText + description: >- + CRFCompletionInstructions reference: Instructions for the clinical site on how to enter collected information on the CRF + cdiscNotes: + any_of: + - range: string + - range: TranslatedText + description: >- + CDISCNotes reference: Explanatory text for the variable + implementationNotes: + description: >- + ImplementationNotes reference: Further information, such as rationale and implementation instructions, on how to implement the CRF data collection fields + any_of: + - range: string + - range: TranslatedText + collectionExceptionCondition: + description: >- + Condition that defines when collection may be exempted + range: Condition + preSpecifiedValue: + description: >- + Prefill value or a default value for a field that is automatically populated. + any_of: + - range: string + - range: TranslatedText + + IsODMStandard: + description: >- + A mixin that provides properties to indicate standards compliance + mixin: true + attributes: + standard: + description: Reference to the standard being implemented + range: Standard + isNonStandard: + description: One or more members of this set are non-standard extensions + range: boolean + + ODMFileMetadata: + description: >- + A mixin that provides ODM file-level metadata attributes including file identifiers, timestamps, and system information + mixin: true + attributes: + fileOID: + description: Unique identifier for the ODM file + range: string + required: true + asOfDateTime: + description: Date and time when the data snapshot was taken + range: datetime + creationDateTime: + description: Date and time when the ODM file was created + range: datetime + required: true + odmVersion: + description: Version of the ODM standard used + range: string + required: true + fileType: + description: Type of ODM file (e.g., Snapshot, Transactional) + range: string + required: true + originator: + description: Organization or system that created the ODM file + range: string + sourceSystem: + description: Source system that generated the data + range: string + sourceSystemVersion: + description: Version of the source system + range: string + context: + description: Define-XML context (usually "Other" for Define-XML) + range: string + defineVersion: + description: Version of Define-XML specification used + range: string + + StudyMetadata: + description: >- + A mixin that provides study-level metadata attributes including study identification and protocol information + mixin: true + attributes: + studyOID: + description: Unique identifier for the study + range: string + required: true + studyName: + description: Name of the study + range: string + studyDescription: + description: Description of the study + range: string + protocolName: + description: Protocol name for the study + range: string + + MetaDataVersion: + tree_root: true + description: >- + A container element that represents a given version of a specification, linking to a particular usage context such as a study, dataset, or data collection instrument. + close_mappings: + - usdm:StudyDesign + is_a: GovernedElement + mixins: + - ODMFileMetadata + - StudyMetadata + attributes: + itemGroups: + description: >- + Item groups, containing items, defined in this version of the metadata + range: ItemGroup + multivalued: true + inlined: true + inlined_as_list: true + items: + description: >- + Template or top-level items (not belonging to any item group) defined in this version of the metadata + range: Item + multivalued: true + inlined: true + inlined_as_list: true + conditions: + description: >- + Logical conditions that apply to this version of the metadata. + range: Condition + multivalued: true + inlined: true + inlined_as_list: true + whereClauses: + description: >- + Data contexts that apply to this version of the metadata. + range: WhereClause + multivalued: true + inlined: true + inlined_as_list: true + methods: + description: >- + Methods defined in this version of the metadata. + range: Method + multivalued: true + inlined: true + inlined_as_list: true + analyses: + description: >- + Analyses defined in this version of the metadata. + range: Analysis + multivalued: true + inlined: true + inlined_as_list: true + codeLists: + description: >- + Code lists defined in this version of the metadata. + range: CodeList + multivalued: true + inlined: true + inlined_as_list: true + codings: + description: Codings defined in this version of the metadata + range: Coding + multivalued: true + inlined: true + inlined_as_list: true + concepts: + description: Structured Concepts defined in this version of the metadata + range: ReifiedConcept + multivalued: true + relationships: + description: >- + Relationships between items, item groups, and other elements in this version of the metadata. + range: Relationship + multivalued: true + inlined: true + inlined_as_list: true + dictionaries: + description: Dictionaries defined in this version of the metadata + range: Dictionary + multivalued: true + inlined: true + inlined_as_list: true + standards: + description: >- + Standards defined in this version of the metadata + range: Standard + multivalued: true + inlined: true + inlined_as_list: true + annotatedCRFs: + description: >- + Reference to annotated case report forms + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true + resources: + description: >- + References to resources and documents that describe this version of the metadata. + any_of: + - range: DocumentReference + - range: Resource + multivalued: true + inlined: true + inlined_as_list: true + dataProducts: + description: >- + Indexed data flows with clear ownership + range: DataProduct + multivalued: true + inlined: true + inlined_as_list: true + displays: + description: >- + Displays defined in this version of the metadata. + range: Display + multivalued: true + inlined: true + inlined_as_list: true + + Item: + description: >- + A data element that represents a specific piece of information within a defined context, with data type, constraints, and derivation methods + close_mappings: + - odm:ItemRef + - odm:ItemDef + - qb:ComponentSpecification + - sdmx:DataAttribute + - sdmx:MetadataAttribute + narrow_mappings: + - fhir:StructureDefinition/variable + - fhir:Questionnaire/item + - qb:ComponentProperty + - omop:Field + - omop:DerivedColumn + related_mappings: + - usdm:BiomedicalConceptProperty + - usdm:DerivationConceptProperty + - usdm:AnalysisConceptProperty + - fhir:ElementDefinition + - qb:Measure + - qb:Attribute + - sdmx:Concept + - sdmx:Component + - sdmx:Representation + - osb:sdtm_variable + - osb:specimen + - osb:unit_dimension + - osb:std_unit + is_a: GovernedElement + mixins: + - IsODMItem + - Formatted + attributes: + dataType: + description: >- + The data type of the item. + range: DataType + required: true + length: + description: >- + The maximum length of the data item in characters. + range: integer + codeList: + description: >- + Reference to the CodeList that constrains the item values. + range: CodeList + method: + description: >- + Reference to the Method element that describes how to derive this item's value. + range: Method + rangeChecks: + description: Range checks applied to this item (e.g. edit checks, CORE rules) + range: RangeCheck + multivalued: true + inlined: true + inlined_as_list: true + applicableWhen: + description: | + References to different situations that define when this item applies. + Multiple whereClauses are combined with OR logic: the item applies if ANY referenced WhereClause matches. + Within each WhereClause, conditions are combined with AND logic: all conditions must be true. + + Example: whereClause: ["WC.SYSBP", "WC.DIABP"] means the item applies when + (all conditions in WC.SYSBP are true) OR (all conditions in WC.DIABP are true). + range: WhereClause + multivalued: true + inlined: false + close_mappings: + - fhir:StructureDefinition/context + origin: + description: >- + The origin of the data + range: Origin + multivalued: true + inlined: true + inlined_as_list: true + conceptProperty: + description: >- + Reference to a abstract concept property that this item is a specialization / instance of. + range: ConceptProperty + + ItemGroup: + description: >- + A collection element that groups related items or subgroups within a specific context, used for tables, FHIR resource profiles, biomedical concept specializations, or form sections + close_mappings: + - odm:ItemGroupDef + - odm:ItemGroupRef + - osb:ActivityInstance + narrow_mappings: + - fhir:StructureDefinition + - fhir:ViewDefinition + - fhir:Questionnaire + - omop:Table + - qb:DataStructureDefinition + - sdmx:DataStructureDefinition + - sdmx:MetaDataStructureDefinition + related_mappings: + - qb:Dataset + - qb:Observation + - qb:ObservationGroup + - qb:Slice + - osb:Activity + is_a: GovernedElement + mixins: + - IsProfile + - IsODMStandard + attributes: + domain: + description: >- + Domain abbreviation for the dataset. + range: string + structure: + description: >- + Data structure of the item group, indicating how the records are organized. + If this is a FHIR Resource, is it nested or flattened? + If this is a structured concept, is it a Biomedical/Derivation/Analysis concept? + any_of: + - range: string + - range: TranslatedText + isReferenceData: + description: >- + Set to Yes if this is a reference item group. + range: boolean + type: + description: >- + Type of item group + range: ItemGroupType + items: + description: Items in this group + range: Item + multivalued: true + close_mappings: + - fhir:StructureDefinition/snapshot + - fhir:StructureDefinition/differential + inlined: true + inlined_as_list: true + keySequence: + description: >- + Ordered list of Items that define the dataset key structure for sorting and uniqueness. + Each entry is an OID reference to an Item in the items array. + Order determines sorting precedence, merge operations, and record uniqueness. + These are allowed to be null, unlike stricter dataset dimensions or primary keys. + range: Item + multivalued: true + close_mappings: + - odm:ItemRef.KeySequence + - sdmx:DimensionDescriptor + slices: + description: >- + Slices are specific subset ItemGroups that belong to, or are used by this ItemGroup + range: ItemGroup + multivalued: true + inlined: true + inlined_as_list: true + implementsConcept: + description: >- + Reference to a abstract concept topic that this item group is a specialization of + range: ReifiedConcept + applicableWhen: + description: | + References to different situations that define when this item applies. + Multiple whereClauses are combined with OR logic: the item applies if ANY referenced WhereClause matches. + Within each WhereClause, conditions are combined with AND logic: all conditions must be true. + + Example: whereClause: ["WC.SYSBP", "WC.DIABP"] means the item applies when + (all conditions in WC.SYSBP are true) OR (all conditions in WC.DIABP are true). + range: WhereClause + multivalued: true + inlined: false + close_mappings: + - fhir:StructureDefinition/context + hasNoData: + description: >- + Used to indicate that this ItemGroup has no data, e.g. for a manifest. + range: boolean + observationClass: + description: >- + Identifies the predefined CDISC model Class. + range: DefClass + required: false + + DefClass: + description: >- + The predefined CDISC model Class that applies to an ItemGroupDef. + attributes: + name: + description: >- + Name of the General Observation Class following CDISC Controlled Terminology. + range: string + required: true + subClasses: + description: >- + One or more SubClasses that further identify the specific SubClass within a Class. + range: SubClass + multivalued: true + required: false + inlined: true + inlined_as_list: true + + SubClass: + description: >- + A specific SubClass within a CDISC model Class. + attributes: + name: + description: >- + Name of the SubClass following CDISC Controlled Terminology for SubClass. + range: string + required: true + parentClass: + description: >- + Name of the parent Class or SubClass following CDISC Controlled Terminology. + range: string + required: false + subClasses: + description: >- + Nested SubClass(es) for multi-level SubClass hierarchy. + range: SubClass + multivalued: true + required: false + inlined: true + inlined_as_list: true + + Relationship: + description: >- + A semantic link that defines connections between elements such as Items or ItemGroups, capturing relationships like "is the unit for" or "assesses seriousness of" + related_mappings: + - sdmx:ConceptSchemeMap + is_a: IdentifiableElement + attributes: + subject: + description: >- + The starting element of the relationship (e.g., an Item or ItemGroup). + range: IdentifiableElement + required: true + object: + description: >- + The ending element of the relationship. + range: IdentifiableElement + required: true + predicateTerm: + description: >- + Short variable relationship linking phrase for programming purposes. + range: PredicateTermEnum + required: true + linkingPhrase: + description: >- + Variable relationship descriptive linking phrase. + range: LinkingPhraseEnum + required: true + + Translation: + description: >- + A text representation that provides content in a specific language, used for multilingual support + exact_mappings: + - odm:TranslatedText + - sdmx:InternationalString + attributes: + "language": + description: The language of the translation + range: string + required: true + "value": + description: The translated text + range: string + required: true + + TranslatedText: + description: >- + A container of the language-specific translations of a single piece of text + (a set of localised strings), as opposed to one Translation. + attributes: + translations: + range: Translation + multivalued: true + inlined: true + inlined_as_list: true + + CodeList: + description: >- + A value set that defines a discrete collection of permissible values for an item, corresponding to the ODM CodeList construct + exact_mappings: + - odm:CodeList + - omop:Vocabulary + - fhir:ValueSet + close_mappings: + - skos:Collection + - sdmx:ItemScheme + - qb:codeList + related_mappings: + - usdm:BiomedicalConceptProperty/responseCodes + narrow_mappings: + - sdmx:Codelist + - sdmx:ValueList + - sdmx:ConceptScheme + is_a: GovernedElement + mixins: + - Versioned + - IsODMStandard + attributes: + dataType: + description: >- + The data type for the values in the code list + range: DataType + formatName: + description: >- + Name of a standard format definition + range: string + codeListItems: + description: >- + The individual values that make up this CodeList. + The type of CodeListItem included determines its behaviour + range: CodeListItem + multivalued: true + inlined: true + inlined_as_list: true + externalCodeList: + description: >- + Reference to a code list that is defined externally to this study + range: Resource + + CodeListItem: + description: >- + A structured member of a CodeList that extends the Coding class with additional context-specific properties + exact_mappings: + - odm:CodeListItem + close_mappings: + - usdm:AliasCode + - usdm:ResponseCode + - fhir:CodeableConcept + - omop:Concept + narrow_mappings: + - sdmx:Code + - sdmx:ValueItem + attributes: + codedValue: + description: >- + The value of the CodeListItem before decoding + range: string + required: true + decode: + description: >- + The decoded value of the CodeListItem + range: string + description: + description: >- + A detailed description of the code (e.g., for documentation purposes) + any_of: + - range: string + - range: TranslatedText + coding: + description: >- + The dictionary definition of the CodeListItem + range: Coding + inlined: true + aliases: + description: Alternative labels for the code (ODM Alias, skos:altLabel) + any_of: + - range: string + - range: TranslatedText + multivalued: true + weight: + description: Numeric significance of the code (e.g., for scoring) + range: decimal + other: + description: >- + Flag to indicate that the term represents "other" content + range: boolean + + Comment: + description: >- + A descriptive element that contains explanatory text provided by a data or metadata handler + exact_mappings: + - odm:CommentDef + - usdm:CommentAnnotation + - fhir:Annotation + - sdmx:Annotation + is_a: GovernedElement + attributes: + text: + description: >- + The comment text. + any_of: + - range: string + - range: TranslatedText + required: true + documents: + description: >- + References to documents that contain or are referenced by this comment + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true + + Coding: + description: >- + A semantic reference that provides standardized codes and their meanings from controlled vocabularies + exact_mappings: + - odm:Coding + - usdm:Code + - fhir:Coding + close_mappings: + - omop:Concept + - skos:Concept + - skos:Label + - sdmx:Code + - sdmx:Concept + - sdmx:ISOConceptReference + attributes: + code: + description: >- + The code value + range: string + required: true + decode: + description: Human-readable meaning + any_of: + - range: string + - range: TranslatedText + exact_mappings: + - skos:prefLabel + codeSystem: + description: >- + The code system identifier + range: string + required: true + codeSystemVersion: + description: >- + The code system version + range: string + aliasType: + description: >- + How this coding is related in the context of its parent element + range: AliasPredicate + + Dictionary: + description: >- + A dictionary that defines a set of codes and their meanings + is_a: IdentifiableElement + mixins: + - Versioned + attributes: + terms: + description: Terms in this dictionary - leave this empty in most cases to keep the file small + range: Coding + multivalued: true + inlined: true + inlined_as_list: true + publishedBy: + description: >- + Associates the Data Provider that reports/publishes the data. + any_of: + - range: Organization + - range: string + + ReifiedConcept: + description: >- + A canonical information layer that makes abstract concepts explicit and referenceable, showing how different data implementations represent the same underlying meanings through a star schema structure with multiple properties + close_mappings: + - sdmx:MetaDataStructureDefinition + - sdmx:Concept + - osb:Activity + narrow_mappings: + - usdm:BiomedicalConcept + - usdm:AnalysisConcept + - usdm:DerivationConcept + related_mappings: + - osb:ActivityInstance + - osb:assm_group + - osb:assm_subgroup + is_a: GovernedElement + mixins: + - Versioned + attributes: + properties: + description: >- + Properties of the reified object, which can be other governed elements or simple values + range: ConceptProperty + multivalued: true + inlined: true + inlined_as_list: true + + ConceptProperty: + description: >- + A reified property concept that exists within the context of its containing topic concept + close_mappings: + - sdmx:MetaDataAttribute + - sdmx:Concept + narrow_mappings: + - usdm:BiomedicalConceptProperty + - usdm:DerivationConceptProperty + - usdm:AnalysisConceptProperty + related_mappings: + - osb:sdtm_variable + - osb:specimen + - osb:unit_dimension + - osb:std_unit + - osb:laterality + - osb:location + - osb:position + is_a: GovernedElement + attributes: + minOccurs: + description: >- + Minimum number of occurrences of this property in the context. + Set to >0 to mandate some number of occurrences + range: integer + maxOccurs: + description: >- + Maximum number of occurrences of this property in the context. + Leave empty for unbounded. Set to 0 to disable property + range: integer + codeList: + description: >- + Reference to a CodeList that constrains the values of this property + range: CodeList + + WhereClause: + description: >- + A conditional element that describes the circumstances under which a containing context applies, linking conditions to structures where they are used + close_mappings: + - sdmx:AttachmentConstraint + related_mappings: + - fhir:StructureDefinition/context + - qb:ObservationGroup + - qb:Slice + - sdmx:CubeRegion + - sdmx:MetadataTargetRegion + is_a: GovernedElement + attributes: + conditions: + description: Logical conditions that apply in this context (combined with AND) + range: Condition + multivalued: true + inlined: false + + Condition: + description: >- + A reusable, composable, and nestable logical construct allowing for complex expressions. + Conditions are most useful when given a meaningful name and linked to Study Definitions. + close_mappings: + - odm:ConditionDef + - usdm:Condition + related_mappings: + - fhir:Expression + - qb:SliceKey + - sdmx:DataConstraint + - sdmx:MetaDataConstraint + - sdmx:DataKeySet + is_a: GovernedElement + attributes: + rangeChecks: + description: Range checks that compose this condition + range: RangeCheck + multivalued: true + inlined: true + inlined_as_list: true + implementsCondition: + description: Reference to a external (e.g. USDM) condition definition that this implements + expressions: + description: >- + Logical expression, resolving to a boolean, that implements this condition in a specific context + range: FormalExpression + multivalued: true + inlined: true + inlined_as_list: true + operator: + description: >- + Logical operator for combining child conditions or range checks. + Defaults to ALL if not specified. + range: LogicalOperator + required: false + conditions: + description: >- + Child conditions to combine using the operator. + Multiple conditions are composed according to the operator (AND/OR/NOT). + Rearrange and nest to compose XOR, or combinations of AND and OR. + Unless the operator is EXPRESSION, in which case the formalExpression is used instead. + Use OID references to reuse conditions defined elsewhere. + range: Condition + multivalued: true + inlined: false + + RangeCheck: + description: >- + A validation element that performs a simple comparison check between a referenced item's value and specified values, resolving to a boolean result + related_mappings: + - qb:SliceKey + - sdmx:DataKey + attributes: + comparator: + description: >- + The type of comparison to be performed + range: Comparator + checkValues: + description: Values to compare against + range: string + multivalued: true + inlined: true + inlined_as_list: true + item: + description: >- + Reference to the Item element whose value is being checked. If not specified, check applies to the enclosing context + any_of: + - range: Item + - range: Dimension + - range: Measure + - range: DataAttribute + softHard: + description: >- + Indicates whether a validation check is an error ("Hard") or a warning ("Soft") + range: SoftHard + expressions: + description: >- + A formal expression for complex checks + range: FormalExpression + multivalued: true + inlined: true + inlined_as_list: true + operator: + description: >- + Logical operator for combining child conditions or range checks. + Defaults to ALL if not specified. + range: LogicalOperator + required: false + + FormalExpression: + description: >- + A computational element that defines the execution of a data derivation within a specific context + exact_mappings: + - odm:FormalExpression + - odm:FormalExpressionRef + - fhir:Expression + is_a: IdentifiableElement + attributes: + context: + description: >- + The specific context within the containing element to which this formal expression applies. + exact_mappings: + - fhir:Expression/language + range: string + expression: + description: >- + The actual text of the formal expression (renamed from 'code' for disambiguation). + range: string + aliases: [code] + required: true + returnType: + description: Return type of the expression + range: string + parameters: + description: Parameters used in the expression + range: Parameter + multivalued: true + inlined: true + inlined_as_list: true + returnValue: + description: Return value details + range: ReturnValue + externalCodeLibs: + description: External code libraries referenced + range: Resource + multivalued: true + + Method: + description: >- + A reusable computational procedure that describes how to derive values and can be referenced by Items. + + Analysis and Derivation concepts can be implemented by a Method. + Properties can be referenced by Parameters in its expressions. + exact_mappings: + - odm:MethodRef + - odm:MethodDef + close_mappings: + - fhir:Expression + - omop:Transformation + is_a: GovernedElement + attributes: + type: + description: >- + The type of method e.g. Computation, Imputation, Transformation. + range: MethodType + expressions: + description: >- + Formal expressions used by this method + range: FormalExpression + multivalued: true + inlined: true + inlined_as_list: true + documents: + description: >- + Reference to a document that describes this method in detail. + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true + implementsConcept: + description: >- + Reference to a specific concept that this Method implements. + range: ReifiedConcept + inlined: false + + SourceItem: + description: >- + A data source that provides the origin of information for an item + attributes: + item: + description: Reference to an item + range: Item + inlined: false + document: + description: Reference to an external document + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true + resource: + description: Path to a resource (e.g. File, FHIR datasource) that is the source of this item + any_of: + - range: Resource + - range: string + multivalued: true + inlined: false + coding: + description: >- + A coding that describes the source of the item + range: Coding + multivalued: true + inlined: true + inlined_as_list: true + + Parameter: + description: >- + A variable element that describes an input used in a formal expression + is_a: IdentifiableElement + attributes: + dataType: + description: >- + The data type of the parameter. + range: DataType + codeList: + description: >- + A list of allowed values for the parameter. + range: CodeList + multivalued: true + value: + description: >- + A specific bound value for the parameter. + range: string + defaultValue: + description: >- + A default value for the parameter. + range: string + items: + description: >- + A list of item dependencies for the parameter. + any_of: + - range: Item + - range: Dimension + - range: Measure + - range: DataAttribute + multivalued: true + inlined: false + conceptProperty: + description: >- + Reference to a specific concept property that this parameter represents or modifies. + range: ConceptProperty + multivalued: true + inlined: false + applicableWhen: + description: >- + References to different situations that define when this parameter + is applicable or required in the containing expression. + Multiple whereClauses are combined with OR logic: the parameter applies + if ANY referenced WhereClause matches. + + Within each WhereClause, conditions are combined with AND logic. + Example: applicableWhen: ["WC.ADULT", "WC.PEDIATRIC"] means the parameter + is needed when (all conditions in WC.ADULT are true) OR + (all conditions in WC.PEDIATRIC are true). + range: WhereClause + multivalued: true + inlined: false + conditions: + description: >- + Validation conditions that constrain this parameter's value beyond controlled terminology. + Multiple conditions are combined with AND logic: all must be satisfied. + Use these for parameter validation rules, distinct from applicableWhen + which determines if the parameter is needed at all. + + Example: A parameter AGE might have conditions ensuring it's >= 0 and <= 120. + or conditions might make up part of a componsed expression. + range: Condition + multivalued: true + inlined: false + required: + description: >- + Indicates whether this parameter must be provided when the + containing expression is evaluated (technical constraint). + range: boolean + ifabsent: 'False' + + ReturnValue: + description: >- + An output specification that defines the details of what a formal expression returns + is_a: IdentifiableElement + attributes: + dataType: + description: >- + The data type of the return value. + range: DataType + valueList: + description: >- + A list of possible return values. + range: string + multivalued: true + + Origin: + description: >- + A provenance element that describes the source of data for an item + attributes: + type: + description: >- + The type of origin: Assigned, Collected, Derived, Protocol, Predecessor, Not Available, or Other. + range: OriginType + source: + description: >- + The source of the data, such as Investigator, Sponsor, Subject, or Vendor. + range: OriginSource + sourceItems: + description: >- + Source items for this origin + range: SourceItem + multivalued: true + inlined: true + inlined_as_list: true + documents: + description: >- + Reference to a document that describes this origin in detail. + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true + + SiteOrSponsorComment: + description: >- + A feedback element that contains comments from a site or sponsor, distinct from the general Comment class + is_a: GovernedElement + attributes: + text: + description: >- + The comment text. + any_of: + - range: string + - range: TranslatedText + required: true + sourceType: + description: >- + who made the comment, such as Investigator, Sponsor. + range: OriginSource + source: + description: >- + ID of the comment provider + any_of: + - range: User + - range: Organization + - range: string + + User: + description: >- + An entity that represents information about a specific user of a clinical data collection or data management system + exact_mappings: + - odm:User + broad_mappings: + - prov:Agent + is_a: IdentifiableElement + attributes: + userType: + description: >- + User's role in the study. + range: UserType + userName: + description: >- + The username of the user. + range: string + fullName: + description: >- + The full name of the user. + range: string + organization: + description: >- + The organization the user belongs to. + close_mappings: + - prov:actedOnBehalfOf + range: Organization + + Organization: + description: >- + An entity that represents organizational information, such as a site or sponsor + exact_mappings: + - odm:Organization + - usdm:Organization + - sdmx:Organisation + broad_mappings: + - prov:Agent + is_a: IdentifiableElement + attributes: + role: + description: >- + The role of the organization in the study. + range: string + type: + description: >- + The type of organization (e.g., site, sponsor, vendor). + range: OrganizationType + location: + description: >- + The physical location of the organization. + range: string + address: + description: >- + The address of the organization. + range: string + partOfOrganization: + description: >- + Reference to a parent organization if this organization is part of a larger entity. + range: Organization + + Standard: + description: >- + A collection element that groups related standards within a specific context, used for defining CDISC implementation guides and controlled terminologies + exact_mappings: + - odm:Standard + is_a: IdentifiableElement + attributes: + name: + description: >- + Name of a standard + range: StandardName + type: + description: >- + Type of a standard + range: StandardType + publishingSet: + description: >- + Publishing Set of a Controlled Terminology + range: PublishingSet + version: + description: >- + Version of an Implementation Guide or of a Controlled Terminology + range: string + status: + description: >- + Status of an Implementation Guide or of a Controlled Terminology + range: StandardStatus + + Resource: + description: >- + An external reference that serves as the source for a Dataset, ItemGroup, or Item + close_mappings: + - odm:Resource + is_a: IdentifiableElement + mixins: + - Versioned + attributes: + resourceType: + description: >- + Type of resource (e.g., "ODM", "HL7-FHIR", "HL7-CDA", "HL7-v2", "OpenEHR-extract") + range: string + required: false + attribute: + description: >- + Field provided by the Name attribute where the data or information can be obtained. + Examples are "valueQuantity.value" or "valueQuantity.unit". + range: string + selection: + description: >- + Machine-executable instructions for selecting data from the resource. + range: FormalExpression + multivalued: true + inlined: true + inlined_as_list: true + + DocumentReference: + description: >- + A comprehensive reference element that points to an external document, combining elements from ODM and FHIR + is_a: IdentifiableElement + mixins: + - Versioned + attributes: + title: + description: Document title + range: string + leafID: + description: Leaf identifier for document reference in Define-XML + range: string + pages: + description: Reference to specific pages in a PDF document + range: integer + multivalued: true + required: false + relationship: + description: Relationship to the referencing entity + range: string + required: false + + Timing: + description: >- + A temporal element that describes the timing of an event or occurrence, which can be absolute, relative, or nominal + exact_mappings: + - usdm:Timing + broad_mappings: + - fhir:Timing + narrow_mappings: + - omop:Observation_period + - omop:Drug_era + - omop:Condition_era + - omop:Procedure_era + - fhir:Period + - fhir:Age + - fhir:Duration + is_a: IdentifiableElement + attributes: + type: + description: >- + The type of timing: Fixed, Before (Relative), or After (Relative). + range: TimingType + required: true + isNominal: + description: >- + Indicates whether the timing is nominal (event-based) or not. + range: boolean + value: + description: >- + The value of the timing, which can be a date/time, duration, or event reference. + range: string + required: true + relativeTo: + description: >- + Reference to the event or occurrence that this timing is relative to. + range: NominalOccurrence + relativeFrom: + description: >- + Reference to the event or occurrence that this timing is relative to. + range: NominalOccurrence + windowLower: + description: Start date/time of the timing + range: datetime + windowUpper: + description: End date/time of the timing + range: datetime + recalled: + description: >- + Indicates whether the timing is recalled or not (recalled timings are less reliable). + range: boolean + frequency: + description: >- + Frequency. Use dose frequency terminology e.g. "BID" if applicable. + range: string + imputation: + description: >- + The imputation method used for the Timing. + range: Method + + NominalOccurrence: + description: >- + An event element that represents occurrences such as planned or unplanned encounters or adverse events + narrow_mappings: + - usdm:ScheduledInstance + - usdm:Encounter + - usdm:InterCurrentEvent + - fhir:PlanDefinition/action + - fhir:ActivityDefinition + - fhir:Encounter + - fhir:AdverseEvent + - omop:Visit_occurrence + - omop:Condition_occurrence + - omop:Procedure_occurrence + related_mappings: + is_a: GovernedElement + attributes: + timing: + description: >- + A named event reference, that can nest further named timing references. + range: Timing + required: true + event: + description: >- + The ID of the event in a Schedule. + range: string + required: false + condition: + description: >- + A condition that must be met for this occurrence to be valid. + range: Condition + multivalued: true + + # New classes for Data Cube, Analysis Concept, and DTA governance + DataStructureDefinition: + description: >- + A structural element that defines the organization of a data cube for analysis, including dimensions, attributes, and measures + close_mappings: + - sdmx:DataStructureDefinition + - qb:DataStructureDefinition + is_a: ItemGroup + attributes: + dimensions: + range: Dimension + multivalued: true + measures: + range: Measure + multivalued: true + attributes: + range: DataAttribute + multivalued: true + grouping: + description: >- + An association to a set of metadata concepts that have an identified + structural role in a Data Structure Definition. + range: ComponentList + evolvingStructure: + range: boolean + ifabsent: 'False' + + Dataflow: + description: >- + An abstract representation that defines data provision for different reference periods, where a Distribution and its Dataset are instances + close_mappings: + - sdmx:Dataflow + related_mappings: + - dprod:Distribution + - dcat:Distribution + - dprod:DataService + - dcat:DataService + is_a: GovernedElement + mixins: + - Versioned + attributes: + structure: + description: >- + Structured component specification for this flow + range: DataStructureDefinition + required: true + dimensionConstraint: + description: >- + Subset of dimensions that are agreed upon by the dataflow and must be included. + range: Dimension + multivalued: true + analysisMethod: + description: >- + Metadata about the analysis method used to produce the data in this dataflow. + range: Analysis + + IsSdmxDataset: + mixin: true + description: >- + A mixin that provides additional metadata specific to SDMX Datasets + attributes: + action: + description: >- + Defines the action to be taken by the recipient system (information, append, replace, delete) + reportingBegin: + description: >- + A specific time period in a known system of time periods that + identifies the start period of a report. + reportingEnd: + description: >- + A specific time period in a known system of time periods that identifies + the end period of a report. + dataExtractionDate: + description: >- + A specific time period that identifies the date and time that the data are + extracted from a data source. + validFrom: + description: >- + Indicates the inclusive start time indicating the validity of the information + in the data set. + validTo: + description: >- + Indicates the inclusive end time indicating the validity of the information in the data set. + publicationYear: + description: >- + Specifies the year of publication of the data or metadata in terms of whatever + provisioning agreements might be in force. + publicationPeriod: + description: >- + Specifies the period of publication of the data or metadata in terms of whatever provisioning + agreements might be in force. + + Dataset: + description: >- + A collection element that groups observations sharing the same dimensionality, expressed as a set of unique dimensions within a Data Product context + close_mappings: + - qb:Dataset + - sdmx:Dataset + - dprod:Dataset + - dcat:Dataset + narrow_mappings: + - sdmx:JsonDataset + - sdmx:CsvDataset + - sdmx:StructureSpecificDataset + is_a: IdentifiableElement + mixins: + - Versioned + - IsProfile + - IsSdmxDataset + attributes: + describedBy: + description: >- + Associates a Dataflow and thereby a Data Structure Definition to the data set. + range: Dataflow + structuredBy: + description: >- + Associates the Data Structure Definition that defines the structure of the Data Set. + Note that the Data Structure Definition is the same as that associated (non-mandatory) to the Dataflow. + range: DataStructureDefinition + publishedBy: + description: >- + Associates the Data Provider that reports/publishes the data. + any_of: + - range: Organization + - range: string + keys: + description: >- + Series and Group keys in the data that are associated with dimensions in this structure + any_of: + - range: SeriesKey + - range: GroupKey + required: true + multivalued: true + inlined: true + inlined_as_list: true + datasetType: + description: Type or classification of the dataset + distribution: + description: Representations of this dataset in various formats or access methods + range: Distribution + multivalued: true + inlined: true + inlined_as_list: true + exact_mappings: + - dcat:distribution + conformsTo: + description: Specification or standard that this dataset conforms to + close_mappings: + - dcterms:conformsTo + hasPolicy: + description: Access or usage policy applied to this dataset + multivalued: true + inlined: true + inlined_as_list: true + informationSensitivityClassification: + description: Classification of the dataset's sensitivity or confidentiality + + DatasetKey: + description: >- + An abstract identifier that comprises the cross-product of dimension values to identify a specific cross-section + abstract: true + exact_mappings: + - sdmx:Key + attributes: + describedBy: + description: >- + Associates the Dimension Descriptor defined in the Data Structure Definition + any_of: + - range: Dimension + - range: ComponentList + keyValues: + description: >- + List of Key Values that comprise each key, separated by a dot + e.g. SUBJ001.VISIT2.BMI + attributeValues: + description: >- + Association to the Attribute Values relating to Key + + GroupKey: + description: >- + A dimension subset that represents collections of dimensions that are subsets of the full dimension set, distinct from SeriesKey which includes Time dimensions + exact_mappings: + - sdmx:GroupKey + is_a: DatasetKey + + SeriesKey: + description: >- + A unique identifier that comprises the cross-product of dimension values including Time to identify observations, representing dimensions shared by all observations in a conceptual series + exact_mappings: + - sdmx:SeriesKey + is_a: DatasetKey + + CubeComponent: + description: >- + An abstract data field that represents a component in a data structure definition, referencing an Item for its definition + abstract: true + exact_mappings: + - sdmx:Component + is_a: GovernedElement + attributes: + item: + description: >- + Reference to the Item that defines this component's data structure and properties + range: Item + required: true + role: + description: >- + The role this component plays in its Structure Definition + missingHandling: + description: >- + The method for handling missing values in the measure property + range: Method + imputation: + description: >- + The imputation method used for the measure property + range: Method + + Measure: + description: >- + A data cube property that describes a measurable quantity or value + exact_mappings: + - qb:MeasureProperty + - sdmx:Measure + is_a: CubeComponent + + Dimension: + description: >- + A data cube property that describes a categorical or hierarchical dimension + exact_mappings: + - qb:DimensionProperty + - sdmx:Dimension + broad_mappings: + - sdmx:DataAttribute + narrow_mappings: + - sdmx:MeasureDimension + - sdmx:TimeDimension + is_a: CubeComponent + + DataAttribute: + description: >- + A data cube property that describes additional characteristics or metadata about observations + exact_mappings: + - qb:AttributeProperty + - sdmx:DataAttribute + is_a: CubeComponent + + ComponentList: + description: >- + An abstract definition that specifies a list of components within a data structure definition, including various descriptor types + exact_mappings: + - sdmx:ComponentList + is_a: IdentifiableElement + attributes: + components: + description: >- + The components that make up this component list + any_of: + - range: Measure + - range: Dimension + - range: DataAttribute + multivalued: true + inlined: true + inlined_as_list: true + + # How a dataset is constructed, by attaching attributes to dimensions and measures at different levels + MeasureRelationship: + description: >- + A relationship element that associates a DataAttribute with a Measure + exact_mappings: + - sdmx:MeasureRelationship + attributes: + measure: + range: Measure + attribute: + range: DataAttribute + + DataflowRelationship: + description: >- + A relationship element that associates a DataAttribute with a Dataflow, reported at the Dataset level + exact_mappings: + - sdmx:DataflowRelationship + attributes: + dataFlow: + range: Dataflow + attribute: + range: DataAttribute + + GroupRelationship: + description: >- + A relationship element that associates a DataAttribute with a set of Dimensions, used when attribute values vary based on all group dimension values + exact_mappings: + - sdmx:GroupRelationship + attributes: + groupKey: + description: >- + Set of dimensions that this definition depends on + exact_mappings: + - sdmx:GroupDimensionDescriptor + range: ComponentList + attribute: + range: DataAttribute + + DimensionRelationship: + description: >- + A relationship element that associates a DataAttribute with a specific Dimension at a specific level + exact_mappings: + - sdmx:DimensionRelationship + attributes: + dimensions: + exact_mappings: + - sdmx:DimensionDescriptor + range: Dimension + multivalued: true + groupKey: + description: >- + Set of dimensions that this definition depends on + exact_mappings: + - sdmx:GroupDimensionDescriptor + range: ComponentList + attribute: + range: DataAttribute + + ObservationRelationship: + description: >- + A relationship element that associates a DataAttribute with an Observation, allowing value-level Items to be reused across multiple different Views + exact_mappings: + - sdmx:ObservationRelationship + attributes: + item: + description: >- + Reference to the Item in an observation context that this definition applies to. + e.g. the SDTM Variable Specialisation for a given Biomedical Concept Property. + exact_mappings: + - sdmx:ObservationDescriptor + range: Item + attribute: + range: DataAttribute + + # DPROD to complement Dataset class and link to DCAT ontology + DataProduct: + description: >- + A governed collection that represents a purpose-driven assembly of datasets and services with an owning team and lifecycle. + The DataProduct defines the boundary of accountability between data producers and consumers. + exact_mappings: + - dprod:DataProduct + - dcat:DataService + is_a: GovernedElement + mixins: + - Versioned + attributes: + dataProductOwner: + description: The person or team accountable for this data product + any_of: + - range: User + - range: Organization + - range: string + exact_mappings: + - prov:wasAttributedTo + domain: + description: The functional domain or business area this product serves + lifecycleStatus: + description: Current lifecycle status of the data product + range: DataProductLifecycleStatus + inputPort: + description: Services that provide input into this data product + range: DataService + multivalued: true + inlined: true + inlined_as_list: true + outputPort: + description: Services that expose output from this data product + range: DataService + multivalued: true + inlined: true + inlined_as_list: true + inputDataflow: + description: >- + Description of the input interface before concrete Datasets exist. + Dataflows referenced here represent the demand side of a ProvisionAgreement. + range: Dataflow + multivalued: true + inlined: true + inlined_as_list: true + close_mappings: + - dcat:distribution + outputDataflow: + description: >- + Description of the output interface before concrete Datasets exist. + Dataflows referenced here represent the supply side of a ProvisionAgreement. + range: Dataflow + multivalued: true + inlined: true + inlined_as_list: true + close_mappings: + - dcat:distribution + inputDataset: + description: Source datasets used by the data product + range: Dataset + multivalued: true + inlined: true + inlined_as_list: true + outputDataset: + description: Output datasets produced by the data product + range: Dataset + multivalued: true + inlined: true + inlined_as_list: true + hasPolicy: + description: Policies governing the use and access of the data product + multivalued: true + inlined: true + inlined_as_list: true + + Distribution: + description: >- + A technical representation that provides a specific format or access method for a dataset + exact_mappings: + - dprod:Distribution + - dcat:Distribution + narrow_mappings: + - sdmx:JsonDataset + - sdmx:CsvDataset + - sdmx:StructureSpecificDataset + attributes: + accessService: + description: Service that provides access to this distribution + range: DataService + conformsTo: + description: The standard or specification the distribution conforms to + any_of: + - range: string + - range: DataStructureDefinition + isDistributionOf: + description: Dataset this distribution represents + range: Dataset + format: + description: File format or serialization used in the distribution + + DataService: + description: >- + A service element that provides an API or endpoint for serving or receiving data + exact_mappings: + - dprod:DataService + - dcat:DataService + is_a: Resource + attributes: + isAccessServiceOf: + description: Distribution(s) for which this service provides access + range: Distribution + protocol: + description: Protocol used by the service (e.g., HTTPS, FTP) + securitySchemaType: + description: Security or authentication method used (e.g., OAuth2) + + DataProvider: + description: >- + An organization element that provides data to a Data Consumer, which can be a sponsor, site, or any other entity that supplies data + close_mappings: + - sdmx:DataProvider + is_a: Organization + attributes: + providesDataFor: + description: >- + The Dataflows that this provider supplies data for + range: Dataflow + multivalued: true + provisionAgreements: + description: >- + The ProvisionAgreements that this provider has with Data Consumers + range: ProvisionAgreement + multivalued: true + source: + description: >- + Association to a data source + range: Resource + multivalued: true + + ProvisionAgreement: + description: >- + An agreement element that describes the contractual relationship between a Data Provider and a Data Consumer regarding data provision + close_mappings: + - sdmx:ProvisionAgreement + is_a: GovernedElement + mixins: + - Versioned + attributes: + provider: + description: >- + The Data Provider that is part of this agreement + range: DataProvider + consumer: + description: >- + The Data Consumer that is part of this agreement + any_of: + - range: DataProduct + - range: Organization + - range: string + dataFlow: + description: >- + The Dataflow that is covered by this agreement + range: Dataflow + source: + description: >- + The source of the data provided under this agreement + range: Resource + + Analysis: + description: >- + Analysis extends Method to capture analysis-specific metadata + including the reason for analysis, its purpose, and data traceability + for the results used. + + Expressions and parameters from Method can be generic or implementation-specific. + is_a: Method + mixins: + - Versioned + attributes: + analysisReason: + description: >- + The reason this analysis was performed. + analysisPurpose: + description: >- + The purpose or role of this analysis in the study. + analysisMethod: + description: >- + Generic method used to perform this analysis. + range: Method + applicableWhen: + description: >- + The conditions (e.g. population, time period etc.) that must be met for this analysis to be applicable. + range: WhereClause + multivalued: true + inlined: false + inputData: + description: >- + Datasets or slices/subsets of datasets asked for by this analysis. + If a Item is referenced by a Parameter e.g. Analysis Variable, make sure to include its parent ItemGroup here. + any_of: + - range: ItemGroup + - range: Dataset + multivalued: true + inlined: false + + Display: + description: >- + A rendered output of an analysis result. + is_a: GovernedElement + mixins: + - Versioned + attributes: + analysis: + description: >- + Analysis result this display represents. + range: Analysis + displayType: + description: >- + The type of display this result represents. + e.g. table, listing, figure, dashboard. + location: + description: >- + Reference to documents / location containing the display. + range: DocumentReference + multivalued: true + inlined: true + inlined_as_list: true +enums: + AliasPredicate: + description: >- + An enumeration that defines permissible values for the relationship between an element and its alias + from_schema: linkml:AliasPredicateEnum + permissible_values: + EXACT_SYNONYM: + description: Codes have identical meaning e.g. "diabetes mellitus" and "DM" + meaning: skos:exactMatch + RELATED_SYNONYM: + description: Codes are related but not equivalent e.g. "diabetes" and "mellitus" + meaning: skos:relatedMatch + BROAD_SYNONYM: + description: Target is broader than source e.g. "diabetes" is broader than "type 2 diabetes" + meaning: skos:broaderMatch + NARROW_SYNONYM: + description: Target is narrower than source e.g. "type 2 diabetes" is narrower than "diabetes" + meaning: skos:narrowerMatch + + Comparator: + description: >- + An enumeration that defines the types of comparison operations available for a RangeCheck + permissible_values: + LT: + description: Less than + LE: + description: Less than or equal + GT: + description: Greater than + GE: + description: Greater than or equal + EQ: + description: Equal + NE: + description: Not equal + IN: + description: In set + NOTIN: + description: Not in set + + UserType: + description: >- + An enumeration that defines the types of users in a clinical data collection or management system + permissible_values: + Sponsor: + Investigator: + Lab: + Other: + Subject: + Monitor: + Data analyst: + Care provider: + Assessor: + + OrganizationType: + description: >- + An enumeration that defines the types of organizations involved in clinical research + permissible_values: + Sponsor: + Site: + CRO: + Lab: + TechnologyProvider: + Other: + + SoftHard: + description: >- + An enumeration that indicates whether a validation check should be treated as an error or a warning + permissible_values: + Soft: + description: Warning + Hard: + description: Error + + MethodType: + description: >- + An enumeration that defines the types of computational methods available for data processing + permissible_values: + Computation: + description: >- + Mathematical computation using values of other items. + Imputation: + description: >- + Assignment of a value based on a estimation (imputation) procedure. + Transformation: + description: >- + Transformation of the item's value according to a standard algorithm, such as a change in units. + Analysis: + description: >- + Creation of analysis results dataset. + Display: + description: >- + Creation of rendered output for display. + + DataType: + description: >- + An enumeration that defines the fundamental data types available for items + permissible_values: + text: + description: >- + Character text with no length restriction. + integer: + description: >- + Integer numbers. + float: + description: >- + Floating-point numbers (decimals). + date: + description: >- + Calendar date. + time: + description: >- + Time of day. + datetime: + description: >- + Calendar date and time of day. + boolean: + description: >- + Logical values (true/false). + double: + description: >- + Double-precision floating-point numbers. + hex: + description: >- + Hexadecimal number. + base64: + description: >- + Base-64 encoded binary data. + hexBinary: + description: >- + Hexadecimal encoded binary data. + durationDatetime: + description: >- + ISO 8601 duration value representing a span of time (e.g., P1Y2M3DT4H5M6S). + + OriginType: + description: >- + An enumeration that defines the types of origins for data items. + Values sourced from NCI Thesaurus subset C170449. + permissible_values: + Assigned: + description: >- + A value that is derived through designation, such as values from a look up table or a label on a CRF. + meaning: NCIT:C170547 + Collected: + description: >- + A value that is actually observed and recorded by a person or obtained by an instrument. + meaning: NCIT:C170548 + Derived: + description: >- + A value that is calculated by an algorithm or reproducible rule, and which is dependent upon other data values. + meaning: NCIT:C170549 + Not Available: + description: >- + A value that is not discoverable or accessible. + meaning: NCIT:C126101 + Other: + description: >- + Different than the one(s) previously specified or mentioned. (NCI) + Predecessor: + description: >- + A value that is copied from another variable. + meaning: NCIT:C170550 + Protocol: + description: >- + A value that is included as part of the study protocol. + meaning: NCIT:C170551 + + OriginSource: + description: >- + An enumeration that defines the sources of data origin + Values sourced from NCI Thesaurus subset C170450. + permissible_values: + Investigator: + text: Investigator + meaning: NCIT:C25936 + Sponsor: + text: Sponsor + meaning: NCIT:C70793 + Subject: + text: Subject + meaning: NCIT:C41189 + Vendor: + text: Vendor + meaning: NCIT:C68608 + + ItemGroupType: + description: >- + An enumeration that defines the roles of an item group within a specific context + permissible_values: + DataCube: + description: >- + A Data Structure Definition for an Analysis Data Cube of dimensions, measures, and attributes. + Table: + description: >- + A simple table or data frame. + Object: + description: >- + An object or profile of a FHIR resource. + DatasetSpecialization: + description: >- + A data specialization of a concept. + ValueList: + description: >- + A list of topic-specific items for a specific column (from Define-XML). + Section: + description: >- + A section of a form. + Form: + description: >- + A data collection form. + + TimingType: + description: >- + An enumeration that defines CDISC timing type values indicating the temporal relationship of an observation to a reference point + permissible_values: + After: + text: After + meaning: NCIT:C201356 + Before: + text: Before + meaning: NCIT:C201357 + Fixed: + text: Fixed + meaning: NCIT:C201358 + + # TODO: Add Enumerated terms for STATO / NCIT analysis concept relationships + + LinkingPhraseEnum: + description: >- + An enumeration that defines variable relationship descriptive linking phrases from the COSMoS SDTM BC model + permissible_values: + assesses seriousness of: + assesses the severity of: + associates the tumor identified in: + decodes the value in: + describes actions taken: + describes relationship of: + describes the outcome of: + further describes the test in: + further specifies the anatomical location in: + groups tumor assessments used in overall response identified by: + groups values in: + groups, within an individual subject, values in: + identifies a pattern of: + identifies an observation described by: + identifies overall response supported by tumor assessments identified by: + identifies the image from the procedure in: + identifies the tumor found by the test in: + indicates occurrence of the value in: + indicates pre-specification of the value in: + indicates severity of: + indicates the previous irradiation status of the tumor identified by: + indicates the progression status of the previous irradiated tumor identified by: + is a dictionary-derived term for the value in: + is a dictionary-derived class code for the value in: + is a dictionary-derived class name for the value in: + is decoded by the value in: + is original text for: + is the administered amount of the treatment in: + is the administration anatomical location for the treatment in: + is the aspect of the event used to define the date in: + is the clinical significance interpretation for: + is the code for the value in: + is the dictionary code for the test in: + is the dictionary-derived term for the value in: + is the dictionary-derived class code for the value in: + is the dictionary-derived class name for the value in: + is the duration for: + is the end date for: + is the epoch of the performance of the test in: + is the frequency of administration of the amount in: + is the identifier for the source data used in the performance of the test in: + is the material type of the subject of the activity in: + is the medical condition that is the reason for the treatment in: + is the method for the test in: + is the part of the body through which is administered the treatment in: + is the physical form of the product in: + is the result of the test in: + is the role of the assessor who performed the test in: + is the specimen tested in: + is the start date for: + is the subject position during performance of the test in: + is the subject's fasting status during the performance of the test in: + is the unit for the value in: + is the unit for: + specifies the anatomical location in: + specifies the anatomical location of: + specifies the anatomical location of the performance of the test in: + specifies the anatomical location of the tumor identified by: + specifies the severity of: + values are grouped by: + was the subject position during performance of the test in: + identifies the reference used in the genomic test in: + indicates heritability of the genetic variant in: + is an identifier for a published reference for the genetic variant in: + is an identifier for the copy, on one of two homologous chromosones, of the genetic variant in: + is an identifier for the genetic sequence of the genetic entity represented by: + is the chromosome that is the position of the result in: + is the clinical trial or treatment setting for: + is the date of occurrence: + is the date of occurrence for: + is the intended disease outcome for: + is the method of secondary analysis of results in: + is the numeric location, within a chromosone, genetic entity, or genetic sub-region, of the result in: + is the symbol for the genomic entity that is the position of the result in: + is the type of genomic entity that is the position of the result in: + is the genetic sub-location of the result in: + is the object of the observation in: + is an identifier for the evaluator with the role in: + is the severity of the toxicity in: + is a grouping of values in: + is the textual description of the intended dose regimen for: + is the reason for stopping administration of: + is the value of the property identified by: + is the name of the reference terminology for: + is the version of the reference terminology in: + + PredicateTermEnum: + description: >- + An enumeration that defines short variable relationship linking phrases for programming purposes from the COSMoS SDTM BC model + permissible_values: + ASSESSES: + CLASSIFIES: + DECODES: + DESCRIBES: + GROUPS: + GROUPS_BY: + IDENTIFIES: + IDENTIFIES_OBSERVATION: + IDENTIFIES_PRODUCT_IN: + IDENTIFIES_TUMOR_IN: + INDICATES: + IS_ATTRIBUTE_FOR: + IS_DECODED_BY: + IS_DERIVED_FROM: + IS_EPOCH_OF: + IS_GROUPED_BY: + IS_INDICATOR_FOR: + IS_ORIGINAL_TEXT_FOR: + IS_POSITION_FOR: + IS_REASON_FOR: + IS_RESULT_OF: + IS_SPECIMEN_TESTED_IN: + IS_SUBJECT_STATE_FOR: + IS_TIMING_FOR: + IS_UNIT_FOR: + PERFORMED: + PERFORMS: + QUALIFIES: + SPECIFIES: + IS_VALUE_OF: + IS_REFERENCE_TERMINOLOGY_FOR: + + DataProductLifecycleStatus: + description: >- + An enumeration that defines the lifecycle stages for a DataProduct + permissible_values: + Ideation: + Design: + Build: + Deploy: + Consume: + + StandardName: + description: >- + An enumeration that defines permissible values for standard names + permissible_values: + ADaMIG: + description: Analysis Data Model Implementation Guide + BIMO: + description: Bioresearch Monitoring + CDISC/NCI: + description: CDISC/NCI Controlled Terminology + SDTMIG: + description: Study Data Tabulation Model Implementation Guide + SDTMIG-AP: + description: SDTMIG Associated Persons + SDTMIG-MD: + description: SDTMIG Medical Devices + SENDIG: + description: Standard for Exchange of Non-clinical Data Implementation Guide + SENDIG-AR: + description: SENDIG Adverse Reactions + SENDIG-DART: + description: SENDIG Developmental and Reproductive Toxicology + SENDIG-GENETOX: + description: SENDIG Genetic Toxicology + + StandardType: + description: >- + An enumeration that defines permissible values for standard types + permissible_values: + CT: + description: Controlled Terminology + IG: + description: Implementation Guide + + PublishingSet: + description: >- + An enumeration that defines permissible values for publishing sets + permissible_values: + ADaM: + description: Analysis Data Model + CDASH: + description: Clinical Data Acquisition Standards Harmonization + DEFINE-XML: + description: Define-XML Standard + SDTM: + description: Study Data Tabulation Model + SEND: + description: Standard for Exchange of Non-clinical Data + + StandardStatus: + description: >- + An enumeration that defines permissible values for standard status + permissible_values: + DRAFT: + description: Draft version of the standard + FINAL: + description: Final version of the standard + + LogicalOperator: + description: >- + Logical operators for combining conditions in Boolean expressions. + For complex expressions, use the EXPRESSION value. + permissible_values: + EXPRESSION: + description: >- + Evaluate condition using expression. Default if expression is present. + AND: + description: >- + All child conditions must be true (all_of). Default if expression is not present. + OR: + description: >- + At least one child condition must be true (any_of). + NOT: + description: >- + Negates the child condition(s) (not_any_of). diff --git a/schema/define.yaml.source b/schema/define.yaml.source new file mode 100644 index 0000000..db12ca4 --- /dev/null +++ b/schema/define.yaml.source @@ -0,0 +1,4 @@ +repo: https://github.com/cdisc-org/DataExchange-DDS +path: model/define.yaml +ref: main +commit: 710f6df84fdfbdc11b369b69b68c3db294478781 diff --git a/scripts/fetch_define_schema.py b/scripts/fetch_define_schema.py new file mode 100644 index 0000000..6265d1c --- /dev/null +++ b/scripts/fetch_define_schema.py @@ -0,0 +1,79 @@ +"""Refresh the vendored define.yaml schema from CDISC DataExchange-DDS. + +The workbench validates generated Define-JSON output against the +LinkML schema published at: + + https://github.com/cdisc-org/DataExchange-DDS/blob/main/model/define.yaml + +That repository is the source of truth. This script re-downloads the +schema and overwrites the local copy at schema/define.yaml, along +with a schema/define.yaml.source file recording the commit it came +from so the vendored copy stays traceable. + +Usage: + python scripts/fetch_define_schema.py [--ref main] +""" + +import argparse +import logging +import urllib.error +import urllib.request +from pathlib import Path + +logger = logging.getLogger(__name__) + +REPO = "cdisc-org/DataExchange-DDS" +SCHEMA_PATH_IN_REPO = "model/define.yaml" +DEST_PATH = Path(__file__).resolve().parent.parent / "schema" / "define.yaml" + + +def _resolve_commit_sha(ref): + url = ( + f"https://api.github.com/repos/{REPO}/commits" + f"?path={SCHEMA_PATH_IN_REPO}&sha={ref}&per_page=1" + ) + with urllib.request.urlopen(url) as response: + import json + + commits = json.load(response) + return commits[0]["sha"] + + +def fetch_define_schema(ref="main"): + """Download define.yaml from DataExchange-DDS to schema/define.yaml.""" + sha = _resolve_commit_sha(ref) + raw_url = f"https://raw.githubusercontent.com/{REPO}/{sha}/{SCHEMA_PATH_IN_REPO}" + logger.info("Fetching %s", raw_url) + try: + with urllib.request.urlopen(raw_url) as response: + content = response.read() + except urllib.error.HTTPError as exc: + raise RuntimeError(f"Failed to download {raw_url}: {exc}") from exc + + DEST_PATH.parent.mkdir(parents=True, exist_ok=True) + DEST_PATH.write_bytes(content) + + source_note = DEST_PATH.with_suffix(".yaml.source") + source_note.write_text( + f"repo: https://github.com/{REPO}\n" + f"path: {SCHEMA_PATH_IN_REPO}\n" + f"ref: {ref}\n" + f"commit: {sha}\n" + ) + logger.info("Wrote %s (commit %s)", DEST_PATH, sha[:12]) + + +def main(): + logging.basicConfig(level=logging.INFO, format="%(message)s") + parser = argparse.ArgumentParser(description=__doc__) + parser.add_argument( + "--ref", + default="main", + help="Branch, tag, or commit to fetch define.yaml from (default: main)", + ) + args = parser.parse_args() + fetch_define_schema(ref=args.ref) + + +if __name__ == "__main__": + main() diff --git a/src/soa_builder.egg-info/PKG-INFO b/src/soa_builder.egg-info/PKG-INFO index 45a14af..acbc707 100644 --- a/src/soa_builder.egg-info/PKG-INFO +++ b/src/soa_builder.egg-info/PKG-INFO @@ -20,6 +20,7 @@ Requires-Dist: python-multipart>=0.0.9 Requires-Dist: jmespath>=1.1.0 Requires-Dist: cdisc-library-client>=0.1.6 Requires-Dist: mcp>=1.0.0 +Requires-Dist: python-docx>=1.1.0 Provides-Extra: dev Requires-Dist: pytest>=7.0.0; extra == "dev" Requires-Dist: pytest-cov>=4.0.0; extra == "dev" @@ -195,6 +196,57 @@ python -m usdm.generate_study_epochs 1 -o epochs.json --- +## MCP Server + +The workbench ships an [MCP (Model Context Protocol)](https://modelcontextprotocol.io/) server that exposes SoA data as tools for Claude agents. This enables workflows such as "analyze this protocol PDF and populate the visit schedule" without copy-paste. + +### Setup + +The server is registered in `.mcp.json` and starts automatically when Claude Code loads the project. Confirm it is listed with `/mcp` in a Claude session. + +The `soa-mcp` command is installed alongside `soa-builder-web`: + +```bash +pip install -e . +soa-mcp # starts the MCP stdio server (for manual testing) +``` + +The server reads `SOA_BUILDER_DB` from the environment (falls back to `soa_builder_web.db`). No web server needs to be running — it accesses the SQLite database directly. + +### Available Tools (11) + +| Tool | Description | +|------|-------------| +| `list_soas` | List all Schedules of Activities | +| `create_soa` | Create a new SoA; returns `soa_id` | +| `get_soa` | Get SoA metadata by id | +| `list_visits` | List visit definitions ordered by `order_index` | +| `create_visit` | Add a visit (name, label, type) | +| `list_activities` | List activities ordered by `order_index` | +| `create_activity` | Add an activity (name, label, description) | +| `assign_instance_activity` | Mark an activity at a ScheduledActivityInstance; use `get_soa_matrix` for ids | +| `get_soa_matrix` | Return the visits × activities grid (instances, activities, cells) | +| `get_usdm_json` | Generate a USDM component as JSON (`full`, `encounters`, `activities`, `biomedical_concepts`, etc.) | +| `get_define_json` | Generate a Define-JSON document (requires `sdtmct` date and `CDISC_API_KEY`) | + +### Configuration + +The `.mcp.json` entry uses the absolute path to the venv console script: + +```json +"soa-workbench": { + "command": "/path/to/.venv/bin/soa-mcp", + "args": [], + "env": { + "SOA_BUILDER_DB": "/path/to/soa_builder_web.db" + } +} +``` + +Update the paths to match your environment after cloning. + +--- + ## Architecture Notes - **Database**: SQLite with WAL mode (production) or DELETE mode (tests) - **Test Isolation**: Tests use `soa_builder_web_tests.db` (set via `SOA_BUILDER_DB` env var) diff --git a/src/soa_builder.egg-info/SOURCES.txt b/src/soa_builder.egg-info/SOURCES.txt index 23a1a6f..9202cfb 100644 --- a/src/soa_builder.egg-info/SOURCES.txt +++ b/src/soa_builder.egg-info/SOURCES.txt @@ -35,6 +35,7 @@ src/soa_builder/web/routers/cdash_terminology.py src/soa_builder/web/routers/cells.py src/soa_builder/web/routers/concept_groups.py src/soa_builder/web/routers/condition_assignments.py +src/soa_builder/web/routers/dair.py src/soa_builder/web/routers/ddf_controlled_terminology.py src/soa_builder/web/routers/decision_instances.py src/soa_builder/web/routers/define_xml_terminology.py @@ -71,6 +72,7 @@ src/usdm/generate_bc_categories.py src/usdm/generate_bc_surrogates.py src/usdm/generate_biomedical_concept_properties.py src/usdm/generate_biomedical_concepts.py +src/usdm/generate_dair.py src/usdm/generate_define_json.py src/usdm/generate_elements.py src/usdm/generate_encounters.py @@ -93,6 +95,7 @@ src/usdm/generate_study_titles.py src/usdm/generate_usdm.py src/usdm/usdm_utils.py tests/test_bc_unassigned_report.py +tests/test_bcp_response_code_cleanup.py tests/test_bulk_import.py tests/test_categories_cache.py tests/test_categories_ui_force.py @@ -101,6 +104,7 @@ tests/test_code_uid_generation.py tests/test_concept_categories.py tests/test_concept_category_force_refresh.py tests/test_concepts_by_category_ui_force.py +tests/test_define_json_concepts.py tests/test_define_json_generator.py tests/test_element_audit_endpoint.py tests/test_element_id_generation.py @@ -113,6 +117,7 @@ tests/test_generate_endpoints.py tests/test_generate_extension_attributes.py tests/test_generate_objectives.py tests/test_instances_audit.py +tests/test_mcp_server.py tests/test_routers_activities.py tests/test_routers_activities_crf.py tests/test_routers_amendments.py @@ -120,6 +125,7 @@ tests/test_routers_arms.py tests/test_routers_audits.py tests/test_routers_bc_categories.py tests/test_routers_bc_surrogates.py +tests/test_routers_dair.py tests/test_routers_decision_instances.py tests/test_routers_delete_soa.py tests/test_routers_elements.py diff --git a/src/soa_builder.egg-info/requires.txt b/src/soa_builder.egg-info/requires.txt index c22a518..3b0d627 100644 --- a/src/soa_builder.egg-info/requires.txt +++ b/src/soa_builder.egg-info/requires.txt @@ -11,6 +11,7 @@ python-multipart>=0.0.9 jmespath>=1.1.0 cdisc-library-client>=0.1.6 mcp>=1.0.0 +python-docx>=1.1.0 [dev] pytest>=7.0.0 diff --git a/src/soa_builder/web/app.py b/src/soa_builder/web/app.py index 7c079cb..26d8b46 100644 --- a/src/soa_builder/web/app.py +++ b/src/soa_builder/web/app.py @@ -72,6 +72,9 @@ _migrate_add_footnote_table, _migrate_add_footnote_audit_table, _migrate_matrix_cells_add_superscript, + _migrate_activity_add_superscript, + _migrate_epoch_add_superscript, + _migrate_visit_add_superscript, _migrate_add_bc_surrogate_table, _migrate_add_activity_surrogate_table, _migrate_add_bc_surrogate_audit_table, @@ -140,6 +143,8 @@ _migrate_add_study_identifier_table, _migrate_add_study_identifier_audit_table, _migrate_soa_add_tool_extension_uids, + _migrate_add_element_intervention_table, + _migrate_backfill_crf_href_latest_version, ) from .routers import activities as activities_router from .routers import arms as arms_router @@ -162,6 +167,7 @@ from .routers import instances as instances_router from .routers import usdm_json as usdm_json_router from .routers import tdd as tdd_router +from .routers import dair as dair_router from .routers import decision_instances as decision_instances_router from .routers import condition_assignments as condition_assignments_router from .routers import footnotes as footnotes_router @@ -196,7 +202,9 @@ ) from .routers.roles import _get_role_type_options, _list_roles from .audit import _record_element_audit - +from usdm.generate_biomedical_concept_properties import ( + populate_biomedical_concept_properties_for_all_soas as _bcp_backfill, +) # Avoid binding visit helpers directly to allow fresh reloads in tests from .schemas import ( @@ -270,6 +278,8 @@ def _configure_logging(): # CRF specializations cache (full list) _crf_specializations_cache = {"data": None, "fetched_at": 0} _CRF_SPECIALIZATIONS_CACHE_TTL = _CONCEPT_CACHE_TTL +# Per-code CRF specializations cache: {code: (fetched_at, [results])} +_crf_specializations_by_code_cache: dict[str, tuple[float, list]] = {} # Category-specific biomedical concepts cache (per category key) _category_concepts_cache: dict[str, dict] = {} _CATEGORY_CONCEPTS_CACHE_TTL = _CONCEPT_CACHE_TTL @@ -329,10 +339,15 @@ def _configure_logging(): _migrate_biomedical_concept_audit() _migrate_backfill_biomedical_concept_codes() _migrate_repoint_stale_bc_code_chains() +if os.environ.get("SOA_EAGER_BCP_POPULATION", "1").strip().lower() not in ("0", "false"): + _bcp_backfill() _migrate_add_soa_id_indexes() _migrate_add_footnote_table() _migrate_add_footnote_audit_table() _migrate_matrix_cells_add_superscript() +_migrate_activity_add_superscript() +_migrate_epoch_add_superscript() +_migrate_visit_add_superscript() _migrate_add_bc_surrogate_table() _migrate_add_activity_surrogate_table() _migrate_add_bc_surrogate_audit_table() @@ -401,6 +416,8 @@ def _configure_logging(): _migrate_add_study_identifier_table() _migrate_add_study_identifier_audit_table() _migrate_soa_add_tool_extension_uids() +_migrate_add_element_intervention_table() +_migrate_backfill_crf_href_latest_version() # Include routers @@ -420,6 +437,7 @@ def _configure_logging(): app.include_router(cells_router.router) app.include_router(usdm_json_router.router) app.include_router(tdd_router.router) +app.include_router(dair_router.router) app.include_router(decision_instances_router.router) app.include_router(condition_assignments_router.router) app.include_router(footnotes_router.router) @@ -645,12 +663,15 @@ def _fetch_matrix(soa_id: int): ) for r in cur.fetchall() ] - # Activities: include optional label/description if schema supports them + # Activities: include optional label/description/superscript if schema supports them cur.execute("PRAGMA table_info(activity)") act_cols = {r[1] for r in cur.fetchall()} + has_superscript = "superscript" in act_cols if "label" in act_cols and "description" in act_cols: + sup_select = ",superscript" if has_superscript else "" cur.execute( - "SELECT id,name,order_index,activity_uid,label,description FROM activity WHERE soa_id=? ORDER BY order_index", + f"SELECT id,name,order_index,activity_uid,label,description{sup_select}" + " FROM activity WHERE soa_id=? ORDER BY order_index", (soa_id,), ) activities = [ @@ -661,6 +682,7 @@ def _fetch_matrix(soa_id: int): activity_uid=r[3], label=r[4], description=r[5], + superscript=r[6] if has_superscript else None, ) for r in cur.fetchall() ] @@ -677,6 +699,7 @@ def _fetch_matrix(soa_id: int): activity_uid=r[3], label=None, description=None, + superscript=None, ) for r in cur.fetchall() ] @@ -1387,12 +1410,18 @@ def _normalize_href(h: Optional[str]) -> Optional[str]: return packages -def fetch_crf_specializations(force: bool = False): +def fetch_crf_specializations(force: bool = False, code: Optional[str] = None): """Return list of CRF specializations as [{'title':..., 'href':...}]. - Fetches the latest package from the CRF packages endpoint, then - retrieves specializations for that package. Sorted alphabetically - by title. Cached with the standard SOA_BUILDER_CACHE_TTL TTL. + When `code` is None: + - Fetch the full "latest version" CRF specializations list. + - Cache the normalized list in _crf_specializations_cache. + + When `code` is provided (e.g. 'C105585'): + - Call the generic dataset specializations endpoint with + ?biomedicalconcept={code}, which returns a HAL-style document. + - Extract the CRF subset from _links.datasetSpecializations.crf. + - Do NOT use or update the main cache (code-specific result only). """ now = time.time() base_prefix = CDISC_CRF_API_BASE_URL @@ -1406,7 +1435,85 @@ def _normalize_href(h): return base_prefix + h return base_prefix + "/" + h - # Return cached result if still fresh + # --------- code-specific branch (use generic endpoint) ---------- + if code: + # Return cached result if still fresh + cached = _crf_specializations_by_code_cache.get(code) + if ( + not force + and cached is not None + and (now - cached[0]) < _CRF_SPECIALIZATIONS_CACHE_TTL + ): + return cached[1] + + url = ( + f"{base_prefix}/mdr/specializations/datasetspecializations" + f"?biomedicalconcept={code}" + ) + headers = {"Accept": "application/json"} + api_key = _get_cdisc_api_key() + subscription_key = os.environ.get("CDISC_SUBSCRIPTION_KEY") or api_key + if subscription_key: + headers["Ocp-Apim-Subscription-Key"] = subscription_key + if api_key: + headers["Authorization"] = f"Bearer {api_key}" + headers["api-key"] = api_key + + try: + resp = requests.get(url, headers=headers, timeout=_HTTP_TIMEOUT) + _crf_specializations_cache["last_status"] = resp.status_code + _crf_specializations_cache["last_url"] = url + _crf_specializations_cache["last_error"] = None + if resp.status_code != 200: + _crf_specializations_cache["last_error"] = f"HTTP {resp.status_code}" + logger.warning( + "CRF specializations by BC code fetch HTTP %s for code=%s", + resp.status_code, + code, + ) + return [] + try: + data = resp.json() + except ValueError: + _crf_specializations_cache["last_error"] = "200 but non-JSON response" + logger.warning( + "CRF specializations by BC code non-JSON body for code=%s", code + ) + return [] + + # Expect HAL-style: _links.datasetSpecializations.crf is list of links + packages: list[dict] = [] + if ( + isinstance(data, dict) + and "_links" in data + and isinstance(data["_links"], dict) + ): + ds = data["_links"].get("datasetSpecializations") + if isinstance(ds, dict): + crf_links = ds.get("crf") + if isinstance(crf_links, list): + for link in crf_links: + if not isinstance(link, dict): + continue + href = _normalize_href(link.get("href")) + title = link.get("title") or href + packages.append({"title": title, "href": href}) + packages.sort(key=lambda p: p.get("title", "").lower()) + logger.info( + "Fetched %d CRF specializations for biomedical concept %s", + len(packages), + code, + ) + _crf_specializations_by_code_cache[code] = (now, packages) + return packages + except Exception as e: + logger.error( + "CRF specializations by BC code fetch error for %s: %s", code, e + ) + _crf_specializations_cache["last_error"] = str(e) + return [] + + # Cache only applies to full list if ( not force and _crf_specializations_cache["data"] is not None @@ -1451,71 +1558,14 @@ def _normalize_href(h): headers["Authorization"] = f"Bearer {api_key}" headers["api-key"] = api_key - # Step 1: fetch package list to determine the latest package href - latest_pkg_href = None - try: - pkg_url = f"{base_prefix}/mdr/specializations/crf/packages" - pkg_resp = requests.get(pkg_url, headers=headers, timeout=_HTTP_TIMEOUT) - _crf_specializations_cache["last_status"] = pkg_resp.status_code - _crf_specializations_cache["last_url"] = pkg_url - _crf_specializations_cache["last_error"] = None - if pkg_resp.status_code == 200: - try: - pkg_data = pkg_resp.json() - except ValueError: - pkg_data = None - # Collect hrefs only — never titles, which aren't valid URL segments - pkg_hrefs = [] - if isinstance(pkg_data, dict) and "_links" in pkg_data: - links = pkg_data["_links"] - for key in ("packages", "crf", "items"): - val = links.get(key) - if isinstance(val, list): - for lnk in val: - if isinstance(lnk, dict): - h = lnk.get("href") or "" - if h: - pkg_hrefs.append(h) - break - elif isinstance(pkg_data, list): - for item in pkg_data: - if isinstance(item, dict): - h = item.get("href") or item.get("packageDate") or "" - if h: - pkg_hrefs.append(str(h)) - if pkg_hrefs: - # Sort descending — date-based hrefs sort lexicographically - pkg_hrefs.sort(reverse=True) - latest_pkg_href = pkg_hrefs[0] - else: - _crf_specializations_cache["last_error"] = ( - f"Packages HTTP {pkg_resp.status_code}: {pkg_resp.text[:180]}" - ) - except Exception as e: - logger.error("CRF packages fetch error: %s", e) - _crf_specializations_cache["last_error"] = str(e) - _crf_specializations_cache.update(data=[], fetched_at=now) - return [] - - if not latest_pkg_href: - logger.warning("CRF packages list returned no package hrefs") - _crf_specializations_cache.update(data=[], fetched_at=now) - return [] - - # Step 2: fetch specializations for the latest package. - # latest_pkg_href may already include "/specializations" as the terminal - # segment (the API returns it that way). Strip it before appending so we - # never produce ".../specializations/specializations". - norm_href = _normalize_href(latest_pkg_href) or latest_pkg_href - base_pkg = norm_href.rstrip("/") - if base_pkg.endswith("/specializations"): - base_pkg = base_pkg[: -len("/specializations")] - spec_url = base_pkg + "/specializations" - packages = [] + # Remote full-list branch: latest-version CRF specializations + url = f"{base_prefix}/mdr/specializations/crf/specializations" + packages: list[dict] = [] try: - resp = requests.get(spec_url, headers=headers, timeout=_HTTP_TIMEOUT) + resp = requests.get(url, headers=headers, timeout=_HTTP_TIMEOUT) _crf_specializations_cache["last_status"] = resp.status_code - _crf_specializations_cache["last_url"] = spec_url + _crf_specializations_cache["last_url"] = url + _crf_specializations_cache["last_error"] = None if resp.status_code == 200: try: data = resp.json() @@ -1557,11 +1607,10 @@ def _normalize_href(h): _crf_specializations_cache["last_error"] = str(e) packages.sort(key=lambda p: (p.get("title") or "").lower()) - _crf_specializations_cache.update(data=packages, fetched_at=now, spec_url=spec_url) + _crf_specializations_cache.update(data=packages, fetched_at=now) logger.info( - "Fetched %d CRF specializations from remote API (package_href=%s)", + "Fetched %d CRF specializations from remote API (latest version list)", len(packages), - latest_pkg_href, ) return packages @@ -1876,8 +1925,8 @@ def _fetch_enriched_instances(soa_id: int): cur.execute( """ SELECT i.id,i.name,i.instance_uid,i.label,i.member_of_timeline, - v.name AS encounter_name,v.label AS encounter_label, - e.name AS epoch_name,e.epoch_label as epoch_label, + v.id AS encounter_id,v.name AS encounter_name,v.label AS encounter_label,v.superscript AS encounter_superscript, + e.id AS epoch_id,e.name AS epoch_name,e.epoch_label as epoch_label,e.superscript AS epoch_superscript, tm.window_label,tm.label AS timing_label,tm.name AS timing_name,tm.value AS study_day FROM instances i LEFT JOIN visit v ON v.encounter_uid = i.encounter_uid AND v.soa_id = i.soa_id @@ -1895,14 +1944,18 @@ def _fetch_enriched_instances(soa_id: int): "instance_uid": r[2], "label": r[3], "member_of_timeline": r[4], - "encounter_name": r[5], - "encounter_label": r[6], - "epoch_name": r[7], - "epoch_label": r[8], - "window_label": r[9], - "timing_label": r[10], - "timing_name": r[11], - "study_day": r[12], + "encounter_id": r[5], + "encounter_name": r[6], + "encounter_label": r[7], + "encounter_superscript": r[8], + "epoch_id": r[9], + "epoch_name": r[10], + "epoch_label": r[11], + "epoch_superscript": r[12], + "window_label": r[13], + "timing_label": r[14], + "timing_name": r[15], + "study_day": r[16], } for r in cur.fetchall() ] @@ -3153,6 +3206,74 @@ def _render_cell_td( ) +def _render_activity_td( + soa_id: int, + activity_id: int, + display_name: str, + superscript: str | None, +) -> str: + """Build the HTML for an activity row header, including superscript and edit button.""" + soa_id_safe = _html.escape(str(soa_id), quote=True) + activity_id_safe = _html.escape(str(activity_id), quote=True) + name_safe = _html.escape(display_name or "") + sup_html = f"{_html.escape(superscript)}" if superscript else "" + edit_btn = ( + f'✎' + ) + return f"{name_safe}{sup_html}{edit_btn}" + + +def _render_encounter_th( + soa_id: int, + encounter_id: int, + display_name: str, + superscript: str | None, +) -> str: + """Build the HTML for an encounter column header, including superscript and edit button.""" + soa_id_safe = _html.escape(str(soa_id), quote=True) + encounter_id_safe = _html.escape(str(encounter_id), quote=True) + name_safe = _html.escape(display_name or "") + sup_html = f"{_html.escape(superscript)}" if superscript else "" + edit_btn = ( + f'✎' + ) + return ( + f'' + f"{name_safe}{sup_html}{edit_btn}" + ) + + +def _render_epoch_th( + soa_id: int, + epoch_id: int, + display_value: str, + colspan: int, + superscript: str | None, +) -> str: + """Build the HTML for a (possibly multi-column) epoch header, including superscript and edit button.""" + soa_id_safe = _html.escape(str(soa_id), quote=True) + epoch_id_safe = _html.escape(str(epoch_id), quote=True) + colspan_safe = _html.escape(str(colspan), quote=True) + value_safe = _html.escape(display_value or "") + sup_html = f"{_html.escape(superscript)}" if superscript else "" + edit_btn = ( + f'✎' + ) + return ( + f'' + f"{value_safe}{sup_html}{edit_btn}" + ) + + @app.post("/ui/soa/{soa_id}/toggle_cell_instance", response_class=HTMLResponse) def ui_toggle_cell_instance( request: Request, @@ -4261,6 +4382,17 @@ def ui_help(request: Request): ) +# UI endpoint for the USDM logical model explorer +@app.get("/ui/usdm-model-explorer", response_class=HTMLResponse) +def ui_usdm_model_explorer(request: Request): + """Render the USDM logical model explorer page.""" + return templates.TemplateResponse( + request, + "usdm_model_explorer.html", + {}, + ) + + # UI endpoint for adding an Activity @app.post("/ui/soa/{soa_id}/add_activity", response_class=HTMLResponse) def ui_add_activity(request: Request, soa_id: int, name: str = Form(...)): @@ -4342,6 +4474,7 @@ def ui_create_soa( def ui_update_meta( request: Request, soa_id: int, + name: Optional[str] = Form(None), study_id: Optional[str] = Form(None), study_label: Optional[str] = Form(None), study_description: Optional[str] = Form(None), @@ -4376,8 +4509,10 @@ def ui_update_meta( % soa_id ) cur.execute( - "UPDATE soa SET study_id=?, study_label=?, study_description=? WHERE id=?", + "UPDATE soa SET name=?, study_id=?, study_label=?," + " study_description=? WHERE id=?", ( + (name or "").strip() or None, new_study_id, (study_label or "").strip() or None, (study_description or "").strip() or None, @@ -4699,7 +4834,9 @@ def ui_edit(request: Request, soa_id: int): cur_inst.execute( """ SELECT i.id,i.name,i.instance_uid,i.label,i.member_of_timeline,st.name AS timeline_name,st.label AS timeline_label, - v.name AS encounter_name,v.label AS encounter_label,e.name AS epoch_name,e.epoch_label as epoch_label,tm.window_label,tm.label AS timing_label,tm.name AS timing_name,tm.value AS study_day + v.id AS encounter_id,v.name AS encounter_name,v.label AS encounter_label,v.superscript AS encounter_superscript, + e.id AS epoch_id,e.name AS epoch_name,e.epoch_label as epoch_label,e.superscript AS epoch_superscript, + tm.window_label,tm.label AS timing_label,tm.name AS timing_name,tm.value AS study_day FROM instances i LEFT JOIN schedule_timelines st ON st.schedule_timeline_uid = i.member_of_timeline AND st.soa_id = i.soa_id LEFT JOIN visit v ON v.encounter_uid = i.encounter_uid AND v.soa_id = i.soa_id @@ -4719,14 +4856,18 @@ def ui_edit(request: Request, soa_id: int): "member_of_timeline": r[4], "timeline_name": r[5], "timeline_label": r[6], - "encounter_name": r[7], - "encounter_label": r[8], - "epoch_name": r[9], - "epoch_label": r[10], - "window_label": r[11], - "timing_label": r[12], - "timing_name": r[13], - "study_day": iso_duration_to_days(r[14]), + "encounter_id": r[7], + "encounter_name": r[8], + "encounter_label": r[9], + "encounter_superscript": r[10], + "epoch_id": r[11], + "epoch_name": r[12], + "epoch_label": r[13], + "epoch_superscript": r[14], + "window_label": r[15], + "timing_label": r[16], + "timing_name": r[17], + "study_day": iso_duration_to_days(r[18]), } for r in cur_inst.fetchall() ] @@ -5129,15 +5270,10 @@ def ui_crf_specializations_list(request: Request): last_error = _crf_specializations_cache.get("last_error") last_url = _crf_specializations_cache.get("last_url") # Extract the /mdr/... path from the resolved specializations URL for display - spec_url = _crf_specializations_cache.get("spec_url") or "" from urllib.parse import urlparse as _up - _p = _up(spec_url) - spec_path = ( - _p.path - if spec_url - else "/mdr/specializations/crf/packages/{package}/specializations" - ) + _p = _up(last_url or "") + spec_path = _p.path or "/mdr/specializations/crf/specializations" return templates.TemplateResponse( request, "crf_specializations.html", @@ -6200,6 +6336,334 @@ def ui_cell_superscript_view( ) +@app.get( + "/ui/soa/{soa_id}/activity_superscript_edit/{activity_id}", + response_class=HTMLResponse, +) +def ui_activity_superscript_edit( + request: Request, + soa_id: int, + activity_id: int, +): + """Return edit-mode for activity superscript inline editing.""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT superscript FROM activity WHERE soa_id=? AND id=?", + (soa_id, activity_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Activity not found") + sup_val = _html.escape(row[0] or "", quote=True) + html = ( + f'' + f'
' + f'' + f'' + f"
" + f'✕' + f"" + ) + return HTMLResponse(html) + + +@app.post( + "/ui/soa/{soa_id}/activity_superscript/{activity_id}", + response_class=HTMLResponse, +) +def ui_activity_superscript_save( + request: Request, + soa_id: int, + activity_id: int, + superscript: Optional[str] = Form(None), +): + """Save superscript value for an activity and return rendered .""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + # Normalise empty string to NULL + sup_val = superscript.strip() if superscript else None + conn = _connect() + cur = conn.cursor() + cur.execute( + "UPDATE activity SET superscript=? WHERE soa_id=? AND id=?", + (sup_val, soa_id, activity_id), + ) + if cur.rowcount == 0: + conn.close() + raise HTTPException(404, "Activity not found") + cur.execute( + "SELECT name, label, superscript FROM activity WHERE soa_id=? AND id=?", + (soa_id, activity_id), + ) + row = cur.fetchone() + conn.commit() + conn.close() + name, label, sup_val_db = row + display_name = label or name + return HTMLResponse( + _render_activity_td(soa_id, activity_id, display_name, sup_val_db) + ) + + +@app.get( + "/ui/soa/{soa_id}/activity_superscript_view/{activity_id}", + response_class=HTMLResponse, +) +def ui_activity_superscript_view( + request: Request, + soa_id: int, + activity_id: int, +): + """Return rendered (view-mode) — used for cancel.""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT name, label, superscript FROM activity WHERE soa_id=? AND id=?", + (soa_id, activity_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Activity not found") + name, label, sup_val = row + display_name = label or name + return HTMLResponse(_render_activity_td(soa_id, activity_id, display_name, sup_val)) + + +@app.get( + "/ui/soa/{soa_id}/encounter_superscript_edit/{encounter_id}", + response_class=HTMLResponse, +) +def ui_encounter_superscript_edit( + request: Request, + soa_id: int, + encounter_id: int, +): + """Return edit-mode for encounter superscript inline editing.""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT superscript FROM visit WHERE soa_id=? AND id=?", + (soa_id, encounter_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Encounter not found") + sup_val = _html.escape(row[0] or "", quote=True) + html = ( + f'' + f'
' + f'' + f'' + f"
" + f'✕' + f"" + ) + return HTMLResponse(html) + + +@app.post( + "/ui/soa/{soa_id}/encounter_superscript/{encounter_id}", + response_class=HTMLResponse, +) +def ui_encounter_superscript_save( + request: Request, + soa_id: int, + encounter_id: int, + superscript: Optional[str] = Form(None), +): + """Save superscript value for an encounter (visit) and return rendered .""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + sup_val = superscript.strip() if superscript else None + conn = _connect() + cur = conn.cursor() + cur.execute( + "UPDATE visit SET superscript=? WHERE soa_id=? AND id=?", + (sup_val, soa_id, encounter_id), + ) + if cur.rowcount == 0: + conn.close() + raise HTTPException(404, "Encounter not found") + cur.execute( + "SELECT name, label, superscript FROM visit WHERE soa_id=? AND id=?", + (soa_id, encounter_id), + ) + row = cur.fetchone() + conn.commit() + conn.close() + name, label, sup_val_db = row + display_name = label or name + return HTMLResponse( + _render_encounter_th(soa_id, encounter_id, display_name, sup_val_db) + ) + + +@app.get( + "/ui/soa/{soa_id}/encounter_superscript_view/{encounter_id}", + response_class=HTMLResponse, +) +def ui_encounter_superscript_view( + request: Request, + soa_id: int, + encounter_id: int, +): + """Return rendered (view-mode) — used for cancel.""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT name, label, superscript FROM visit WHERE soa_id=? AND id=?", + (soa_id, encounter_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Encounter not found") + name, label, sup_val = row + display_name = label or name + return HTMLResponse( + _render_encounter_th(soa_id, encounter_id, display_name, sup_val) + ) + + +@app.get( + "/ui/soa/{soa_id}/epoch_superscript_edit/{epoch_id}", + response_class=HTMLResponse, +) +def ui_epoch_superscript_edit( + request: Request, + soa_id: int, + epoch_id: int, + colspan: int = 1, +): + """Return edit-mode for epoch superscript inline editing. + + ``colspan`` is a render-time pass-through (how many matrix columns + the epoch header currently spans) — it is not stored in the + database and must be preserved across the edit/save/view swaps so + the table stays aligned. + """ + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT superscript FROM epoch WHERE soa_id=? AND id=?", + (soa_id, epoch_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Epoch not found") + sup_val = _html.escape(row[0] or "", quote=True) + colspan_safe = _html.escape(str(colspan), quote=True) + html = ( + f'' + f'
' + f'' + f'' + f'' + f"
" + f'✕' + f"" + ) + return HTMLResponse(html) + + +@app.post( + "/ui/soa/{soa_id}/epoch_superscript/{epoch_id}", + response_class=HTMLResponse, +) +def ui_epoch_superscript_save( + request: Request, + soa_id: int, + epoch_id: int, + superscript: Optional[str] = Form(None), + colspan: int = Form(1), +): + """Save superscript value for an epoch and return rendered .""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + sup_val = superscript.strip() if superscript else None + conn = _connect() + cur = conn.cursor() + cur.execute( + "UPDATE epoch SET superscript=? WHERE soa_id=? AND id=?", + (sup_val, soa_id, epoch_id), + ) + if cur.rowcount == 0: + conn.close() + raise HTTPException(404, "Epoch not found") + cur.execute( + "SELECT epoch_label, name, superscript FROM epoch WHERE soa_id=? AND id=?", + (soa_id, epoch_id), + ) + row = cur.fetchone() + conn.commit() + conn.close() + epoch_label, name, sup_val_db = row + display_value = epoch_label or name + return HTMLResponse( + _render_epoch_th(soa_id, epoch_id, display_value, colspan, sup_val_db) + ) + + +@app.get( + "/ui/soa/{soa_id}/epoch_superscript_view/{epoch_id}", + response_class=HTMLResponse, +) +def ui_epoch_superscript_view( + request: Request, + soa_id: int, + epoch_id: int, + colspan: int = 1, +): + """Return rendered (view-mode) — used for cancel.""" + if not soa_exists(soa_id): + raise HTTPException(404, "SOA not found") + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT epoch_label, name, superscript FROM epoch WHERE soa_id=? AND id=?", + (soa_id, epoch_id), + ) + row = cur.fetchone() + conn.close() + if not row: + raise HTTPException(404, "Epoch not found") + epoch_label, name, sup_val = row + display_value = epoch_label or name + return HTMLResponse( + _render_epoch_th(soa_id, epoch_id, display_value, colspan, sup_val) + ) + + # UI endpoint for associating a Transition Start Rule with Visit/Encounter (visit.transitionStartRule) @app.post( "/ui/soa/{soa_id}/set_visit_transition_start_rule", response_class=HTMLResponse diff --git a/src/soa_builder/web/codelist_config.py b/src/soa_builder/web/codelist_config.py new file mode 100644 index 0000000..4b95960 --- /dev/null +++ b/src/soa_builder/web/codelist_config.py @@ -0,0 +1,52 @@ +"""Configurable CDISC CT codelist codes for UI dropdowns. + +Each constant identifies the CDISC controlled terminology codelist +whose terms populate a specific dropdown in the UI. Override any of +these via the corresponding ``CODELIST_*`` variable in ``config.env`` +to point that dropdown at an alternate/custom codelist. + +This module calls ``load_dotenv("config.env")`` itself (mirroring +``db.py``/``migrate_database.py``) so the configured values are +available regardless of module import order relative to +``app.py``'s own ``load_dotenv`` call. +""" + +import os + +from dotenv import load_dotenv + +load_dotenv("config.env") + +EPOCH_TYPE_CODELIST = os.environ.get("CODELIST_EPOCH_TYPE", "C99079") +ARM_TYPE_CODELIST = os.environ.get("CODELIST_ARM_TYPE", "C174222") +ARM_DATA_ORIGIN_TYPE_CODELIST = os.environ.get( + "CODELIST_ARM_DATA_ORIGIN_TYPE", "C188727" +) +ROLE_TYPE_CODELIST = os.environ.get("CODELIST_ROLE_TYPE", "C215480") +ORGANIZATION_TYPE_CODELIST = os.environ.get("CODELIST_ORGANIZATION_TYPE", "C215480") +AMENDMENT_REASON_CODELIST = os.environ.get("CODELIST_AMENDMENT_REASON", "C207415") +AMENDMENT_IMPACT_TYPE_CODELIST = os.environ.get( + "CODELIST_AMENDMENT_IMPACT_TYPE", "C215481" +) +GEOGRAPHIC_SCOPE_TYPE_CODELIST = os.environ.get( + "CODELIST_GEOGRAPHIC_SCOPE_TYPE", "C207412" +) +GOVERNANCE_DATE_TYPE_CODELIST = os.environ.get( + "CODELIST_GOVERNANCE_DATE_TYPE", "C207413" +) +STUDY_TITLE_TYPE_CODELIST = os.environ.get("CODELIST_STUDY_TITLE_TYPE", "C207419") +INTERVENTION_ROLE_CODELIST = os.environ.get("CODELIST_INTERVENTION_ROLE", "C207417") +INTERVENTION_TYPE_CODELIST = os.environ.get("CODELIST_INTERVENTION_TYPE", "C99078") +INTERVENTION_UNIT_CODELIST = os.environ.get("CODELIST_INTERVENTION_UNIT", "C66781") +OBJECTIVE_LEVEL_CODELIST = os.environ.get("CODELIST_OBJECTIVE_LEVEL", "C188725") +ENDPOINT_LEVEL_CODELIST = os.environ.get("CODELIST_ENDPOINT_LEVEL", "C188726") +ENCOUNTER_ENVIRONMENTAL_SETTING_CODELIST = os.environ.get( + "CODELIST_ENCOUNTER_ENVIRONMENTAL_SETTING", "C127262" +) +ENCOUNTER_CONTACT_MODE_CODELIST = os.environ.get( + "CODELIST_ENCOUNTER_CONTACT_MODE", "C171445" +) +TIMING_TYPE_CODELIST = os.environ.get("CODELIST_TIMING_TYPE", "C201264") +TIMING_RELATIVE_TO_FROM_CODELIST = os.environ.get( + "CODELIST_TIMING_RELATIVE_TO_FROM", "C201265" +) diff --git a/src/soa_builder/web/migrate_database.py b/src/soa_builder/web/migrate_database.py index 5c1183b..ebaa923 100644 --- a/src/soa_builder/web/migrate_database.py +++ b/src/soa_builder/web/migrate_database.py @@ -2,6 +2,7 @@ import logging import os import pathlib +import re from datetime import datetime, timezone from typing import Dict, Optional @@ -1435,6 +1436,51 @@ def _migrate_matrix_cells_add_superscript(): logger.warning("matrix_cells superscript migration failed: %s", e) +def _migrate_activity_add_superscript(): + """Add superscript TEXT column to activity if missing.""" + try: + conn = _connect() + cur = conn.cursor() + cur.execute("PRAGMA table_info(activity)") + if "superscript" not in {r[1] for r in cur.fetchall()}: + cur.execute("ALTER TABLE activity ADD COLUMN superscript TEXT") + conn.commit() + logger.info("Added superscript column to activity") + conn.close() + except Exception as e: + logger.warning("activity superscript migration failed: %s", e) + + +def _migrate_epoch_add_superscript(): + """Add superscript TEXT column to epoch if missing.""" + try: + conn = _connect() + cur = conn.cursor() + cur.execute("PRAGMA table_info(epoch)") + if "superscript" not in {r[1] for r in cur.fetchall()}: + cur.execute("ALTER TABLE epoch ADD COLUMN superscript TEXT") + conn.commit() + logger.info("Added superscript column to epoch") + conn.close() + except Exception as e: + logger.warning("epoch superscript migration failed: %s", e) + + +def _migrate_visit_add_superscript(): + """Add superscript TEXT column to visit if missing.""" + try: + conn = _connect() + cur = conn.cursor() + cur.execute("PRAGMA table_info(visit)") + if "superscript" not in {r[1] for r in cur.fetchall()}: + cur.execute("ALTER TABLE visit ADD COLUMN superscript TEXT") + conn.commit() + logger.info("Added superscript column to visit") + conn.close() + except Exception as e: + logger.warning("visit superscript migration failed: %s", e) + + def _migrate_add_bc_surrogate_table(): """Create biomedical_concept_surrogate table if missing.""" try: @@ -3203,6 +3249,28 @@ def _migrate_add_study_identifier_audit_table(): logger.warning("_migrate_add_study_identifier_audit_table failed: %s", e) +def _migrate_add_element_intervention_table(): + """Create element_intervention junction table for StudyElement ↔ StudyIntervention.""" + try: + conn = _connect() + cur = conn.cursor() + cur.execute( + "CREATE TABLE IF NOT EXISTS element_intervention (" + "id INTEGER PRIMARY KEY AUTOINCREMENT," + "soa_id INTEGER NOT NULL," + "element_id INTEGER NOT NULL," + "intervention_uid TEXT NOT NULL," + "order_index INTEGER," + "UNIQUE(soa_id, element_id, intervention_uid)" + ")" + ) + conn.commit() + conn.close() + logger.info("_migrate_add_element_intervention_table complete") + except Exception as e: + logger.warning("_migrate_add_element_intervention_table failed: %s", e) + + def _migrate_soa_add_tool_extension_uids(): """Create soa_tool_extension table for stable per-SOA USDM tool UIDs. @@ -3250,3 +3318,45 @@ def _migrate_soa_add_tool_extension_uids(): conn.close() except Exception as e: logger.warning("_migrate_soa_add_tool_extension_uids failed: %s", e) + + +def _migrate_backfill_crf_href_latest_version(): + """Rewrite activity_concept_crf.crf_href from the dated-package + format to the latest-version format, e.g.: + /mdr/specializations/crf/packages/2026-06-30/specializations/TEMP + -> /mdr/specializations/crf/specializations/TEMP + Idempotent: rows already in the new format are left untouched.""" + pattern = re.compile(r"/mdr/specializations/crf/packages/[^/]+/specializations/") + replacement = "/mdr/specializations/crf/specializations/" + try: + conn = _connect() + cur = conn.cursor() + cur.execute( + "SELECT name FROM sqlite_master WHERE type='table'" + " AND name='activity_concept_crf'" + ) + if not cur.fetchone(): + conn.close() + return + cur.execute( + "SELECT id, crf_href FROM activity_concept_crf" + " WHERE crf_href LIKE '%/mdr/specializations/crf/packages/%'" + ) + rows = cur.fetchall() + updated = 0 + for row_id, href in rows: + new_href = pattern.sub(replacement, href) + if new_href != href: + cur.execute( + "UPDATE activity_concept_crf SET crf_href=? WHERE id=?", + (new_href, row_id), + ) + updated += 1 + if updated: + conn.commit() + logger.info( + "_migrate_backfill_crf_href_latest_version updated %d rows", updated + ) + conn.close() + except Exception as e: + logger.warning("_migrate_backfill_crf_href_latest_version failed: %s", e) diff --git a/src/soa_builder/web/routers/_freeze_helpers.py b/src/soa_builder/web/routers/_freeze_helpers.py index 1ce7003..5bd3853 100644 --- a/src/soa_builder/web/routers/_freeze_helpers.py +++ b/src/soa_builder/web/routers/_freeze_helpers.py @@ -293,8 +293,13 @@ def _capture_biomedical_concepts(cur, soa_id: int) -> list: if not _table_has_columns(cur, "biomedical_concept", ("biomedical_concept_uid",)): return [] cur.execute( - "SELECT biomedical_concept_uid,name,label,code" - " FROM biomedical_concept WHERE soa_id=? ORDER BY id", + "SELECT bc.biomedical_concept_uid, bc.name, bc.label, bc.code, c.code" + " FROM biomedical_concept bc" + " LEFT JOIN alias_code a" + " ON bc.code = a.alias_code_uid AND bc.soa_id = a.soa_id" + " LEFT JOIN code c" + " ON a.standard_code = c.code_uid AND a.soa_id = c.soa_id" + " WHERE bc.soa_id=? ORDER BY bc.id", (soa_id,), ) return [ @@ -303,6 +308,7 @@ def _capture_biomedical_concepts(cur, soa_id: int) -> list: "name": r[1], "label": r[2], "code": r[3], + "concept_id": r[4], } for r in cur.fetchall() ] @@ -757,13 +763,24 @@ def _get_concept_list(m, key): title_changes.append( {"code": code, "old_title": l_title, "new_title": r_title} ) + titles = { + c["code"]: c.get("title") or c["code"] + for c in la + ra + if isinstance(c, dict) and c.get("code") + } if added or removed or title_changes: concept_changes_all.append( { "activity_id": aid, + "activity_name": ( + r_act.get(aid, {}).get("name") + or l_act.get(aid, {}).get("name") + or f"Activity {aid}" + ), "added": added, "removed": removed, "title_changes": title_changes, + "titles": titles, } ) @@ -832,7 +849,7 @@ def _get_concept_list(m, key): ( "biomedical_concepts", "biomedical_concept_uid", - ["name", "label", "code"], + ["name", "label", "code", "concept_id"], ), ( "bc_properties", @@ -860,6 +877,7 @@ def _get_concept_list(m, key): "added": ea, "removed": er, "changed": ec, + "data_unavailable": snap_key not in l_snap or snap_key not in r_snap, } def _truncate(lst): @@ -887,6 +905,7 @@ def _truncate(lst): "added": ea, "removed": er, "changed": ec, + "data_unavailable": raw["data_unavailable"], } entity_meta[snap_key] = { "added_total": len(raw["added"]), diff --git a/src/soa_builder/web/routers/activities.py b/src/soa_builder/web/routers/activities.py index 99c0d5c..8f0a67e 100644 --- a/src/soa_builder/web/routers/activities.py +++ b/src/soa_builder/web/routers/activities.py @@ -1350,7 +1350,7 @@ def ui_crf_options( """Return