Key clinical point: In patients with inoperable locally advanced/metastatic triple-negative breast cancer (TNBC), the overall survival benefit with add-on ipatasertib was not statistically significant but numerically longer.
Major finding: The median overall survival with ipatasertib plus paclitaxel vs placebo plus paclitaxel was 25.8 months vs. 16.9 months (hazard ratio, 0.80; 95% confidence interval, 0.50-1.28). The most common grade ≥3 adverse events in the ipatasertib vs placebo groups were diarrhea (23% vs. 0%) and neutropenia (10% vs. 2%).
Study details: A multicenter, randomized, double-blind phase 2 study of 124 patients with inoperable locally advanced/metastatic TNBC who were randomly assigned to receive first-line paclitaxel with either ipatasertib or placebo.
Disclosures: This study was supported by F. Hoffmann-La Roche Ltd. The authors received honoraria, research funding, consultancy/advisory fees, travel/accommodation/expenses, and research funding. Some authors or their spouses were employed and/or held stocks and/or had ownership in companies.
Source: Dent R et al. Breast Cancer Res Treat. 2021;189:377-386. doi: 10.1007/s10549-021-06143-5 .