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|Therapy Name||Abemaciclib + Elacestrant|
|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).|
|Elacestrant||Orserdu||RAD1901||Hormone - Anti-estrogens 25||Orserdu (elacestrant) is a selective estrogen receptor degrader that down-regulates ER and ER-regulated genes, resulting in anti-tumor activity and may be effective in cells resistant to CDK4/6 inhibitors (PMID: 28473534, PMID: 31852484). Orserdu (elacestrant) is FDA approved for use in postmenopausal women or adult men with ER-positive, ERBB2 (HER2)-negative, ESR1 (ER alpha)-mutated advanced or metastatic breast cancer progressed on endocrine therapy (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|
|NCT04791384||Phase Ib/II||Abemaciclib + Elacestrant||Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer||Recruiting||USA||0|
|NCT06062498||Phase II||Abemaciclib + Elacestrant Elacestrant Elacestrant + Palbociclib Elacestrant + Ribociclib||Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer||Not yet recruiting||USA||0|
|NCT05386108||Phase Ib/II||Abemaciclib + Elacestrant||Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer (ELECTRA)||Recruiting||USA | ITA | GBR | ESP | DEU | BEL||2|
|NCT05563220||Phase Ib/II||Alpelisib + Elacestrant Elacestrant + Ribociclib Elacestrant + Everolimus Elacestrant + Palbociclib Abemaciclib + Elacestrant||Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer (ELEVATE)||Recruiting||USA||0|