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|Therapy Name||Abemaciclib + Fulvestrant + Trastuzumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Abemaciclib||Verzenio||LY2835219||CDK4/6 Inhibitor 10||Verzenio (abemaciclib) is a dual CDK4/6 inhibitor, which inhibits Rb1 protein phosphorylation and may induce cell cycle arrest and prevent growth in cancer cells (PMID: 24919854). Verzenio (abemaciclib) is FDA approved as a monotherapy and in combination with Faslodex (fulvestrant) in patients with hormone receptor-positive (ESR, PGR) and ERBB2 (HER2) receptor-negative advanced or metastatic 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).|
|Trastuzumab||Herceptin||Anti HER2||HER2 (ERBB2) Antibody 47||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|
|ERBB2 positive||Her2-receptor positive breast cancer||predicted - sensitive||Abemaciclib + Fulvestrant + Trastuzumab||Phase II||Actionable||In a Phase II trial, the combination therapy of Verzenio (abemaciclib), Herceptin (trastuzumab), and Faslodex (fulvestrant) in patients with ERBB2 (HER2)-receptor positive breast cancer (n=79) resulted in safety and a greater progression-free survival (PFS) compared to patients treated with standard of care chemotherapy plus Herceptin (trastuzumab) (n=79), demonstrating a PFS of 8.3 months versus 5.7 months (p=0.051), respectively (PMID: 32353342; NCT02675231).||32353342|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT02675231||Phase II||Trastuzumab Abemaciclib + Trastuzumab Abemaciclib + Fulvestrant + Trastuzumab||A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)||Active, not recruiting|