Multinational phase 3 trial of fulvestrant with or without capivasertib for hormone receptor-positive advanced breast cancer

AKT pathway activation is implicated in endocrine-therapy resistance. The multinational phase 3 CAPItello-291 trial evaluated addition of the AKT inihibitor capivasertib to fulvestrant for patients with HR-positive, HER2-negative advanced breast cancer whose disease had progressed during or after aromatase inhibitor therapy with or without a CDK4/6 inhibitor. The median progression-vree survival was longer with capivasertib-fulvestrant than with placebo-fulvestrant, both in the overall population (7.2 months versus 3.6 months; HR 0.60; p<0.001) and in the population with AKT pathway-altered tumors (7.3 months versus 3.1 months; HR 0,50; p<0.001). Adverse events leading to discontinuation were reported in 13.0% of the patients in the capivasertib-fulvestrant group and 2.3% of the patients in the placebo-fulvestrant group (quick take video summary).