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|Therapy Name||Abemaciclib + Amcenestrant|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Abemaciclib||Verzenio||LY2835219||CDK4/6 Inhibitor 13||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, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer, in combination with endocrine therapy as adjuvant treatment for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative, node-positive, early breast cancer at high risk of recurrence, and in combination with an aromatase inhibitor as initial therapy for patients with hormone receptor-positive, ERBB2 (HER2) receptor-negative advanced or metastatic breast cancer (FDA.gov).|
|Amcenestrant||SAR-439859|SAR 439859|SAR439859||Hormone - Anti-estrogens 25||Amcenestrant (SAR439859) is a selective estrogen receptor degrader that down-regulates ER expression and signaling, resulting in tumor cell growth inhibition (Cancer Res 2017;77(4 Suppl):Abstract nr P3-04-05, PMID: 31721572).|
|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|
|NCT03284957||Phase Ib/II||Amcenestrant Alpelisib + Amcenestrant Amcenestrant + Palbociclib Abemaciclib + Amcenestrant Amcenestrant + Everolimus||Phase 1 / 2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer||Active, not recruiting||USA | ITA | FRA | ESP | CAN | BEL||4|
|NCT01042379||Phase II||Trilaciclib Trastuzumab Duocarmazine Cyclophosphamide + Doxorubicin Cemiplimab Amcenestrant Abemaciclib + Amcenestrant Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel + Trastuzumab Amcenestrant + Letrozole Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel Pertuzumab + Trastuzumab + Trilaciclib Paclitaxel + Trastuzumab Pertuzumab + Trastuzumab Cemiplimab + Fianlimab||I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer||Recruiting||USA||0|