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Combining Alpelisib (BYL719) with fulvestrant improved progression-free survival versus fulvestrant alone in postmenopausal women and men with HR-positive, HER2-negative, PIK3CA-mutant advanced or metastatic breast cancer that progressed after aromatase inhibitor treatment with or without a CDK4/6 inhibitor, meeting the primary endpoint of the phase III SOLAR-1 trial.