Key clinical point: In patients with germline BRCA1/2-wildtype metastatic triple-negative breast cancer (TNBC) with a BRCA-like phenotype, cisplatin plus veliparib significantly improved progression-free survival (PFS) without causing any unprecedented adverse events.
Major finding: PFS was significantly improved with cisplatin+veliparib vs cisplatin+placebo (hazard ratio 0.57; log-rank P = .01) in patients with BRCA-like TNBC, but not in germline BRCA1/2-mutated (P = .54) and non-BRCA-like (P = .57) groups. No new toxicity signals were observed.
Study details: Findings are from the phase 2 S1416 study including 320 patients with metastatic TNBC (n = 305) or estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/both ER and PR positive, human epidermal growth factor receptor 2-negative BC (n = 15) who were randomly assigned to receive cisplatin with either veliparib or placebo.
Disclosures: This study was funded by the US National Cancer Institute and other sources. Some authors declared receiving grants, payments, or honoraria from; serving on advisory boards for; or having other financial or non-financial ties with several sources.
Source: Rodler E 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 (Jan 6). Doi: 10.1016/S1470-2045(22)00739-2