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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 18||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|
|PIK3CA E545K||estrogen-receptor positive breast cancer||predicted - sensitive||Alpelisib + Fulvestrant||Case Reports/Case Series||Actionable||In a clinical case study, Faslodex (fulvestrant) plus Piqray (Alpelisib) resulted in a 14% reduction of measurable brain metastases and induced regression of non-measurable brain metastases in an ER-positive, PR-positive, HER2-negative breast cancer patient harboring PIK3CA E545K; follow-up brain scan at 4 months showed mixed response that was compatible with stable disease, and the patient ultimately demonstrated progression of parenchymal disease at 6 months following treatment (PMID: 32923889).||32923889|
|PIK3CA H1047R||estrogen-receptor positive breast cancer||predicted - sensitive||Alpelisib + Fulvestrant||Case Reports/Case Series||Actionable||In a clinical case study, Faslodex (fulvestrant) plus Piqray (Alpelisib) in an ER-positive, PR-positive, HER2-negative breast cancer patient harboring PIK3CA H1047R and TP53 H179Q induced moderate regression of multiple non-measurable brain metastases with no new or progressive lesions at 4 weeks, and resulted in stable CNS lesions at 10 weeks; however, the patient demonstrated progression in the liver, and a liquid biopsy showed acquisition of ESR1 Y537N with a 1.4% minor allele frequency (PMID: 32923889).||32923889|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|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||USA||4|
|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||USA | CAN||17|