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|Therapy Name||Alpelisib + Pertuzumab + Trastuzumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Alpelisib||Piqray||BYL719||PIK3CA inhibitor 21||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).|
|Pertuzumab||Perjeta||2C4 Antibody||HER2 (ERBB2) Antibody 64||Perjeta (pertuzumab) is a monoclonal antibody that binds ERBB2 (HER2) to prevent dimerization and subsequent HER signaling, thereby resulting in apoptosis and tumor growth inhibition (PMID: 15699478). Perjeta (pertuzumab) is FDA approved in combination with Herceptin (trastuzumab) and Taxotere (docetaxel) for patients with ERBB2 (HER2)-positive breast cancer and in combination with Herceptin (trastuzumab) and chemotherapy as neoadjuvant treatment for patients with ERBB2 (HER2)-positive breast cancer (FDA.gov).|
|Trastuzumab||Herceptin||Anti HER2||HER2 (ERBB2) Antibody 64||Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (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|
|NCT04208178||Phase III||Pertuzumab + Trastuzumab Alpelisib + Pertuzumab + Trastuzumab||Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (EPIK-B2)||Active, not recruiting||USA | ITA | FRA | ESP | BEL||3|