Randomized phase 2 trial of cisplatin with veliparib or placebo for metastatic TNBC and BRCA mutation-associated breast cancer

Studies evaluating PARP inhibitors plus platinum-based chemotherapy for germline BRCA1/2-wildtype TNBC are scarce. A large proportion of these tumors shows homologous recombination deficiency, resulting in a BRCA-like phenotype. The multicenter randomized phase 2 S1416 trial evaluated cisplatin with veliparib or placebo for three groups of metastatic breast cancer: germline BRCA1/2-mutated, BRCA-like, and non-BRCA-like. The study showed that addition of veliparib to cisplatin significantly improved progression-free survival in patients with BRCA-like metastatic TNBC, but not in patients with non-BRCA-like metastatic breast cancer.