Andre F, et al. - This randomized, phase 3 trial was performed on 572 patients with HR-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who already received endocrine therapy to assess the efficacy of alpelisib (300 mg per day) plus fulvestrant (500 mg every 28 days and once on day 15) vs placebo plus fulvestrant. A total of 341 patients out of 572 were confirmed for tumor-tissue PIK3CA mutations. Result suggests that alpelisib-fulvestrant treatment prolonged progression-free survival in these patients with PIK3CA-mutation.