Double-blind placebo (PBO)-controlled randomized phase III trial evaluating first-line ipatasertib (IPAT) combined with paclitaxel (PAC) for PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer (aTNBC): primary results from IPATunity130 cohort A
In cohort A of IPATunity 130, a double-blind placebo-controlled randomized Phase III trial, first-line ipatasertib combined with paclitaxel was evaluated in patients with PIK3CA/AKT1/PTEN-altered locally advanced unresectable or metastatic triple-negative breast cancer. The primary endpoint was investigator-assessed PFS; secondary endpoints included overall survival, objective response rate, duration of response, clinical benefit rate, patient-reported outcomes, and safety.