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
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) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 12
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
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
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
NCT04469764 Phase II Abemaciclib + Anastrozole Abemaciclib + Letrozole Abemaciclib Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer Recruiting USA 0
NCT04614194 Phase II Letrozole Abemaciclib + Letrozole Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib Recruiting USA 0
NCT04049227 Phase I Abemaciclib + Letrozole Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer Recruiting USA 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
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
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
NCT04393285 Phase II Abemaciclib + Letrozole Abemaciclib and Letrozole to Treat Endometrial Cancer Recruiting USA 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 Not yet recruiting USA 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 0
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 Recruiting 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


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