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Breast cancer (invasive) · line 2 · Talazoparib monotherapy (gBRCA-mutant HER2- locally advanced or metastatic breast)

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

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Source YAML: dossier complet

Ligne thérapeutique2
Voiestandard
Régime liéREG-TALAZOPARIB-MONO-BREAST
IDIND-BREAST-BRCA-MET-TALAZOPARIB
TypeIndication
Étatreviewed 2026-04-29 | pending_clinical_signoff
MaladiesDIS-BREAST
SourcesSRC-EMBRACA-LITTON-2018 SRC-ESMO-BREAST-METASTATIC-2024 SRC-NCCN-BREAST-2025

Notes

EMBRACA (NCT01945775): Phase III, gBRCA1/2-mutant HER2- locally advanced or metastatic breast cancer (≤3 prior cytotoxic regimens for advanced disease). Talazoparib 1 mg PO daily vs physician's- choice single-agent chemo. Median PFS 8.6 vs 5.6 mo (HR 0.54); ORR 62.6% vs 27.2%. OS not significantly different at final analysis (HR 0.85, p=0.17). FDA approval Oct 2018. This indication is the HR+/HER2- BRCA-mut variant; TNBC variant is IND-BREAST-TNBC -2L-BRCA-TALAZOPARIB. Olaparib OlympiAD (PFS 7.0 vs 4.2 mo, HR 0.58) is overlapping option; selection driven by AE profile — talazoparib has higher anemia / transfusion burden (~39% G≥3 vs ~16% with olaparib) but greater PARP-trapping potency. Pre-start: germline BRCA1/2 panel (peripheral blood) confirmed pathogenic/likely-pathogenic. UA access: talazoparib registered; NSZU does not cover for breast — out-of-pocket.

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