Combining Alpelisib (BYL719) with fulvestrant (Faslodex) improved progression-free survival versus fulvestrant alone in postmenopausal women and men with hormone receptor (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.
–wild-type tumors including 5 with ER-positive/HER2-negative breast cancer, 1 in the dose-escalation phase and 4 in the dose-expansion phase. The most common primary cancer sites were breast (n = 36; 26.9%), colorectal (n = 35; 26.1%), and head and neck (n = 19; 14.2%).
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