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|Therapy Name||Alpelisib + Fulvestrant + Metformin|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Alpelisib||Piqray||BYL719||PIK3CA inhibitor 18||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 24||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).|
|Metformin||Glucophage||Apo-Metformin||mTOR Inhibitor 51||Glucophage (metformin) inhibits part of the mitochondrial respiratory chain and may exert antineoplastic effects through inhibition of mTOR and is FDA approved for type 2 diabetes (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||Covered Countries||Other Countries|
|NCT04899349||Phase II||Alpelisib + Fulvestrant + Metformin Alpelisib + Dapagliflozin + Fulvestrant + Metformin||Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (EPIK-B4)||Active, not recruiting||USA||2|
|NCT04300790||Phase II||Alpelisib + Fulvestrant + Metformin||Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients (METALLICA)||Active, not recruiting||ESP||0|