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Therapy Name | Ado-trastuzumab emtansine + Alpelisib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Ado-trastuzumab emtansine | Kadcyla | T-DM1|trastuzumab emtansine | HER2 (ERBB2) Antibody 76 HER2 (ERBB2) Antibody-Drug Conjugate 31 | Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate (ADC) comprising the ERBB2 (HER2) monoclonal antibody trastuzumab and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov). |
Alpelisib | Piqray | BYL719 | PIK3CA inhibitor 24 | 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT02038010 | Phase I | Ado-trastuzumab emtansine + Alpelisib | BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx | Completed | USA | 0 |