Breast cancer (invasive) · line 1 · Inavolisib + palbociclib + fulvestrant (HR+/HER2- PIK3CA-mutant 1L metastatic post-adjuvant ET recurrence)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Line of therapy | 1 |
|---|---|
| Track | standard |
| Linked regimen | REG-INAVOLISIB-PALBO-FULV-BREAST |
| ID | IND-BREAST-HR-POS-1L-INAVOLISIB |
|---|---|
| Type | Indication |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | DIS-BREAST |
| Sources | SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025 |
Notes
ESCAT IA. INAVO120 (NCT04191499): inavolisib + palbociclib + fulvestrant in PIK3CA-mutant HR+/HER2- metastatic breast with endocrine-resistant disease (recurrence on/within 12 mo of completing adjuvant endocrine therapy, or de-novo metastatic). Median PFS 15.0 vs 7.3 mo (HR 0.43). FDA approval Oct 2024 (Itovebi). Mutant-selective design yields lower hyperglycemia + rash burden than alpelisib while preserving efficacy. Pre-treatment PIK3CA testing (tissue NGS or ctDNA) required. Trial-source SRC-INAVO120-TURNER-2024 not yet ingested into KB — citations fall back to NCCN + ESMO guideline Sources; flagged for follow-up source-stub generation. UA access barrier: inavolisib not registered; named-patient import / EAP only.
Used By
Handbook Chapters
HB-BREAST-HR-POS-HER2-NEG-1L- HR+/HER2- metastatic breast cancer: first-line reasoning