Therapy Detail
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| Therapy Name | Abemaciclib + Letrozole |
| 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). |
| Letrozole | Femara | Letrozol | Aromatase Inhibitor 3 | Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis, and is approved for postmenopausal women 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT04393285 | Phase II | Abemaciclib + Letrozole | Abemaciclib and Letrozole to Treat Endometrial Cancer | Active, not recruiting | USA | 0 |
| NCT04964934 | Phase III | Abemaciclib + Camizestrant Letrozole + Palbociclib Abemaciclib + Letrozole Anastrozole + Palbociclib Abemaciclib + Anastrozole Camizestrant + Palbociclib | Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (SERENA-6) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 13 |
| 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 |
| NCT05872204 | Phase II | Abemaciclib + Letrozole | Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer (ALEPRO) | Recruiting | NLD | FRA | BEL | 0 |
| 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 |
| NCT04227327 | Phase II | Abemaciclib + Letrozole Abemaciclib + Anastrozole | Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) (HERMIONE-7) | Active, not recruiting | ITA | 0 |
| NCT02057133 | Phase I | Abemaciclib + Loperamide + Pertuzumab + Trastuzumab Abemaciclib + Fulvestrant + LY3023414 Abemaciclib + Letrozole Abemaciclib + Exemestane Abemaciclib Abemaciclib + Everolimus + Exemestane Abemaciclib + Anastrozole Abemaciclib + Tamoxifen Abemaciclib + Trastuzumab | A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread | Active, not recruiting | USA | 0 |
| NCT06139107 | Phase I | Abemaciclib + Letrozole | RADIANT: Pre-op Radiation With Abemaciclib and Letrozole | Recruiting | USA | 0 |
| NCT05952557 | Phase III | Tamoxifen Abemaciclib + Tamoxifen Abemaciclib + Exemestane Abemaciclib + Camizestrant Abemaciclib + Letrozole Abemaciclib + Anastrozole Exemestane Anastrozole Letrozole | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (CAMBRIA-2) | Recruiting | USA | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 32 |
| NCT04614194 | Phase II | Letrozole Abemaciclib + Letrozole | Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib | Recruiting | USA | 0 |
| NCT04293393 | Phase II | Cyclophosphamide + Docetaxel + Doxorubicin Abemaciclib + Letrozole Abemaciclib + Goserelin + Letrozole Abemaciclib + Letrozole + Leuprolide Cyclophosphamide + Doxorubicin + Paclitaxel | Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients (CARABELA) | Active, not recruiting | ESP | 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 |
| NCT04049227 | Phase I | Abemaciclib + Letrozole | Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer | Unknown status | USA | 0 |
| NCT04469764 | Phase II | Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib | Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer | Recruiting | USA | 0 |
| NCT03675893 | Phase II | Abemaciclib + LY3023414 Abemaciclib + Letrozole Abemaciclib + Letrozole + Metformin Abemaciclib + Letrozole + LY3023414 | Abemaciclib + Letrozole +/- Metformin in Recurrent or Persistent Endometrial Cancer | Recruiting | USA | 0 |
| NCT03988114 | FDA approved | Abemaciclib + Anastrozole Abemaciclib + Letrozole | A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (proMONARCH) | Withdrawn | USA | ITA | DEU | BEL | AUT | 4 |
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