Talazoparib is a poly ADP ribose polymerase (PARP) inhibitor, an investigational anticancer drug with probable activity in breast cancer patients with germline BRCA (gBRCA) mutation. This study aims to assess the safety and efficacy of talazoparib in patients with advanced breast cancer and gBRCA1/2 mutations.
This randomized, phase-3, open-label trial included a total of 431 patients with advanced breast cancer and gBRCA mutations. The patients were randomly assigned in a 2:1 ratio to receive talazoparib (n=287) or standard therapy (n=147). The primary outcome of the study was progression-free survival assessed by blinded independent central review.
The median progression-free survival was 8.6 months in the talazoparib group, compared with 5.6 months in the standard therapy group. The interim median hazard ratio for death was 0.76. The patients in the talazoparib group also experienced a higher objective response rate (62.6%), as compared with standard therapy (27.2%). Hematologic grade 3-4 events were reported in 55% of the patients in the talazoparib group and 38% of the patients in the standard therapy group.
The research concluded that single-agent talazoparib was associated with improved outcomes over standard therapy in patients with advanced breast cancer and gBRCA mutations.