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.

Source YAML: complete record

Components	`DRUG-INAVOLISIB` `DRUG-PALBOCICLIB` `DRUG-FULVESTRANT`

ID	`REG-INAVOLISIB-PALBO-FULV-BREAST`
Type	Regimen
Status	pending_clinical_signoff
Diseases	None declared
Sources	`SRC-ESMO-BREAST-METASTATIC-2024` `SRC-NCCN-BREAST-2025`

Notes

INAVO120 (NCT04191499): Phase III, PIK3CA-mut HR+/HER2- metastatic breast cancer with disease recurrence on/after adjuvant endocrine therapy. Inavolisib + palbociclib + fulvestrant vs placebo + palbociclib + fulvestrant. Median PFS 15.0 vs 7.3 mo (HR 0.43). FDA approval Oct 2024 (Itovebi). Pre-treatment PIK3CA testing (tissue NGS or ctDNA) required. Mutant-selective inavolisib design yields lower hyperglycemia + rash burden than alpelisib while preserving efficacy. Trial-source SRC-INAVO120-TURNER-2024 not yet ingested into KB — citation falls back to NCCN + ESMO guideline Sources; flagged for follow-up source-stub generation.

Used By

Indication

IND-BREAST-HR-POS-1L-INAVOLISIB - IND-BREAST-HR-POS-1L-INAVOLISIB