In this randomized, double-blind, placebo-controlled, phase 2 trial, investigators evaluated the efficacy of cisplatin in combination with veliparib in germline BRCA1/2-mutated, BRCA-like, and non-BRCA-like metastatic breast cancer. This study was performed at 154 community and academic clinical sites in the United States. Participants included those who were at least 18 years of age, had an Eastern Cooperative Oncology Group performance status of 0 to 2, had been diagnosed with metastatic or recurrent triple-negative breast cancer or germline BRCA1/2-associated metastatic or recurrent breast cancer, and had been given up to one line of chemotherapy for metastatic disease.

Patients in the study were randomly assigned 1:1 to be given cisplatin (75 mg/m2; day 1) in combination with either veliparib or matching placebo (300 mg orally twice a day; days 1–14) on a cycle of 21 days. Based on the results of the trial, it was found that the combination of veliparib and cisplatin showed considerable improvement in progression-free survival (PFS) in those with BRCA-like metastatic triple-negative breast cancer.

Reference: Rodler E, Sharma P, Barlow WE, et al. Cisplatin with veliparib or placebo in metastatic triple-negative breast cancer and BRCA mutation-associated breast cancer (S1416): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2023;24(2):162-174. doi:10.1016/S1470-2045(22)00739-2