
SOLAR-1 and BYLieve trials documented the efficacy of the PI3K-inhibitor alpelisib in pre-treated PIK3CA-mutant, hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer (ABC) patients. The study report real-life data of patients prospectively registered in the French alpelisib early access program (EAP) opened to PIK3CA-mutant HR+/HER2- ABC patients treated with alpelisib and fulvestrant. In multivariable analysis, characteristics significantly associated with a shorter PFS were age < 60 years, > five lines of prior treatments and the C420R PI3KCA mutation patients discontinued alpelisib due to adverse events. This is the largest real-life assessment of alpelisib efficacy. In addition, despite heavy pre-treatments, patients derived a clinically relevant benefit from alpelisib and fulvestrant.
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