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|Therapy Name||Alpelisib + Fulvestrant|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Alpelisib||Piqray||BYL719||PIK3CA inhibitor 16||Piqray (Alpelisib) is a selective PIK3CA inhibitor that blocks activation of the PI3K signaling pathway and inhibits tumor growth (PMID: 23726034). Piqray (Alpelisib) is FDA approved in combination with fulvestrant for use in postmenopausal women, and men, with advanced or metastatic hormone receptor (HR)-positive, ERBB2 (HER2)-negative, PIK3CA-mutant breast cancer (FDA.gov).|
|Fulvestrant||Faslodex||ICI 182,780||Hormone - Anti-estrogens 17||Faslodex (fulvestrant) is a competitive inhibitor of estrogen that binds and deforms estrogen receptors, and causes inhibition of growth in cultured estrogen-sensitive breast cancer cells and is FDA approved for use in patients with hormone receptor-positive breast cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT01219699||Phase I||Alpelisib Alpelisib + Fulvestrant||A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene||Completed|
|NCT03056755||Phase II||Alpelisib + Fulvestrant Alpelisib + Letrozole||Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (BYLieve)||Recruiting|