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
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
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
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
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
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
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
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
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
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
NCT04305236 Phase II Abemaciclib + Fulvestrant Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer Terminated USA 0
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
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 | DEU | CAN | BEL | AUS 16
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
NCT05305924 Phase II Fulvestrant Abemaciclib + Fulvestrant Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer Recruiting USA 0
NCT06409390 Phase I Fulvestrant + Ribociclib Trastuzumab deruxtecan Sacituzumab govitecan-hziy Capecitabine Abemaciclib + Fulvestrant Cyclophosphamide + Docetaxel + Sargramostim Pilot Study of Sequential Therapies Modeled on Evolutionary Dynamics for Breast 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 Recruiting USA 0


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