Talazoparib monotherapy (gBRCA-mutant HER2- locally advanced or metastatic breast)
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.
| Components | DRUG-TALAZOPARIB |
|---|
| ID | REG-TALAZOPARIB-MONO-BREAST |
|---|---|
| Type | Regimen |
| Status | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-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 (capecitabine / eribulin / gemcitabine / vinorelbine). 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. Greater PARP-trapping potency than olaparib — anemia is dose-limiting AE (~53% any grade, ~39% G≥3); transfusion support frequently required. Germline BRCA1/2 testing (peripheral blood) required pre-start. Monotherapy alternative to olaparib OlympiAD; head-to-head not done.
Used By
Handbook Chapters
HB-BREAST-HR-POS-HER2-NEG-1L- HR+/HER2- metastatic breast cancer: first-line reasoning
Indication
IND-BREAST-BRCA-MET-TALAZOPARIB- IND-BREAST-BRCA-MET-TALAZOPARIB