Therapy Detail
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| Therapy Name | Abemaciclib + Fulvestrant |
| Synonyms | |
| Therapy Description | |
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| 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). |
| Fulvestrant | Faslodex | ICI 182,780 | Hormone - Anti-estrogens 25 | 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT04256941 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Palbociclib Letrozole + Palbociclib Fulvestrant + Ribociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Anastrozole | Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study | Completed | USA | 0 |
| NCT05933395 | Phase II | Abemaciclib + Fulvestrant Fulvestrant + Neratinib Alpelisib + Fulvestrant Everolimus + Fulvestrant | Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor (GERTRUDE) | Recruiting | USA | 0 |
| NCT06065748 | Phase III | Fulvestrant + Palbociclib Abemaciclib + Fulvestrant Giredestrant + Ribociclib Giredestrant + Palbociclib Abemaciclib + Giredestrant Fulvestrant + Ribociclib | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) | Recruiting | USA | NZL | ITA | FRA | ESP | CAN | BEL | AUS | 12 |
| NCT03939897 | Phase Ib/II | Abemaciclib + Fulvestrant Abemaciclib + Copanlisib + Fulvestrant | Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
| NCT05696626 | Phase III | Abemaciclib + Fulvestrant Abemaciclib + Lasofoxifene | Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 9 |
| NCT05169567 | Phase III | Fulvestrant Abemaciclib + Fulvestrant | Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMONARCH) | Active, not recruiting | USA | ITA | FRA | ESP | BEL | 12 |
| NCT05826964 | Phase II | Everolimus + Fulvestrant Exemestane + Ribociclib Everolimus + Tamoxifen Fulvestrant + Ribociclib Everolimus + Exemestane Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Alpelisib + Letrozole Abemaciclib + Exemestane Fulvestrant + Palbociclib Alpelisib + Fulvestrant Letrozole + Palbociclib Exemestane + Palbociclib Anastrozole + Ribociclib Letrozole + Ribociclib Abemaciclib + Fulvestrant | Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | Recruiting | USA | 0 |
| NCT03643510 | Phase II | Abemaciclib + Fulvestrant | Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer | Active, not recruiting | USA | 0 |
| NCT02107703 | Phase III | Abemaciclib + Fulvestrant Fulvestrant | A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 12 |
| NCT05305924 | Phase II | Fulvestrant Abemaciclib + Fulvestrant | Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer | Recruiting | USA | 0 |
| NCT04352777 | Phase II | Abemaciclib + Letrozole Abemaciclib + Anastrozole Abemaciclib + Fulvestrant | Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer | Active, not recruiting | USA | 0 |
| NCT04920708 | Phase II | Fulvestrant + Ribociclib Fulvestrant + Ipatasertib + Palbociclib Fulvestrant + Palbociclib Abemaciclib + Fulvestrant | Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (FAIM) | Recruiting | GBR | 0 |
| NCT04305236 | Phase II | Abemaciclib + Fulvestrant | Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer | Terminated | USA | 0 |
| NCT04158362 | Phase III | Capecitabine Abemaciclib + Fulvestrant Abemaciclib + Letrozole Paclitaxel Abemaciclib + Anastrozole | Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer (AMBRE) | Recruiting | FRA | 0 |
| NCT05362760 | FDA approved | Abemaciclib + Exemestane Abemaciclib + Fulvestrant Abemaciclib + Letrozole Abemaciclib + Anastrozole | Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management (MINERVA) | Recruiting | DEU | 1 |
| NCT04031885 | FDA approved | Abemaciclib + Fulvestrant | A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer | Terminated | USA | 1 |
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