Therapy Detail
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| Therapy Name | Abemaciclib + Elacestrant |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Abemaciclib | Verzenio | LY2835219 | CDK4/6 Inhibitor 14 | 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 29 | 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). |
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| 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 | TUR | POL | LUX | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | BRA | BEL | AUS | ARG | 1 |
| 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 ER+/HER-2- Breast Cancer (ELECTRA) | Recruiting | USA | TUR | ITA | GRC | GBR | FRA | ESP | DEU | BEL | 1 |
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