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Talazoparib in Somatic BRCA Mutant Metastatic Breast Cancer
NCT03990896Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2021
- Primary completion
- Mar 2027
- Countries
- 1
- Sponsor
- Massachusetts General Hospital
- Modality
- Small Molecules
- Drugs
- talazoparib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of talazoparib in breast cancer, sponsored by Massachusetts General Hospital. Primary endpoint: Progression-Free Survival at 2 years. Started Nov 2021; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Talazoparib
Talazoparib will be provided as capsules for oral administration daily
03
Who it enrols
Adults with metastatic breast cancer with deleterious somatic BRCA 1 or 2 mutations, who have progressed on at least one prior therapy, with adequate organ function and ECOG <= 2.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Serious Adverse Events
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