Clinical trials: Abemaciclib
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
HR+/HER2- Breast Cancer, Metastatic Disease
Abemaciclib for the Treatment of Luminal Metastatic breAst caNcer in the Real-life Clinical pracTice in Russia.
The ATLANT study is prospective, multicentre, non-interventional, observational study. Patients with HR+/HER2-negative metastatic breast cancer received abemaciclib as monotherapy or in combination with endocrine therapy.
- Conditions
- HR+/HER2- Breast Cancer, Metastatic Disease, Аdvanced Disease
- Trial name
- ATLANT (NCT05789771)
- Testing
- Abemaciclib
- Where
- Russia
- Volunteers
- 136 people
- Sponsor
- Blokhin's Russian Cancer Research Center
Neoplasm, Neoplasm Metastasis
A Study of LY2835219 in Participants With Cancer
The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin.
- Trial name
- NCT02117648
- Testing
- Abemaciclib, Clarithromycin
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04305834
- Testing
- Abemaciclib, Questionnaire Administration
- Where
- 6 sites in United States
- Volunteers
- 43 people
- Sponsor
- City of Hope Medical Center
Cancer, Tumors
The Drug Rediscovery Protocol (DRUP Trial)
This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs* prescribed for treatment of patients with advanced cancer with a…
- Conditions
- Cancer, Tumors, Neoplasm, Neoplasia
- Trial name
- DRUP (NCT02925234)
- Testing
- Panitumumab, Olaparib, Dabrafenib
- Where
- 36 sites in Netherlands
- Volunteers
- 1,550 people
- Sponsor
- The Netherlands Cancer Institute
Hepatic Insufficiency
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
The study involves a single dose of a study drug called abemaciclib taken by mouth. The purpose of this study will be to measure how much study drug gets into the blood stream and how long the body takes to get rid of it when…
- Trial name
- NCT02387814
- Testing
- Abemaciclib
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer
TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer.
- Trial name
- NCT05548127
- Testing
- ARV-471, Abemaciclib
- Where
- 37 sites in United States, Canada and 2 more
- Volunteers
- 37 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
- Trial name
- Morpheus-panBC (NCT03424005)
- Testing
- Capecitabine, Atezolizumab, Ipatasertib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 1,132 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, Stage IV Breast Cancer
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.
- Conditions
- Metastatic Breast Cancer, Stage IV Breast Cancer, Breast Cancer, Breast Cancer Stage IV
- Trial name
- NCT06678269
- Testing
- Abemaciclib, Radiation Therapy
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Healthy
A Study of Abemaciclib in Healthy Participants
The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s).
- Trial name
- NCT02672423
- Testing
- Abemaciclib Capsules (Reference Formulation), Abemaciclib Tablet (Test Formulation)
- Where
- 2 sites in United States
- Volunteers
- 127 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Breast Cancer Female
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery.
- Trial name
- POETIC-A (NCT04584853)
- Testing
- Abemaciclib, Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
- Where
- 62 sites in United Kingdom
- Volunteers
- 123 people
- Sponsor
- Institute of Cancer Research, United Kingdom
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain.
- Conditions
- CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation
- Trial name
- NCT03994796
- Testing
- Abemaciclib, PI3K Inhibitor paxalisib, Entrectinib
- Where
- 435 sites in United States
- Volunteers
- 50 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Breast Cancer
Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer
This is a prospective, open-label, single-center, randomized controlled Phase II clinical study aimed at evaluating the efficacy and safety of neoadjuvant imlunestrant combined with abemaciclib guided by the Ki67 index after 2…
- Trial name
- NCT07410559
- Testing
- Imlunestrant + abemaciclib, (dd)EC*4-T*4
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Fudan University
Breast Neoplasm Female
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line…
- Trial name
- NCT03425838
- Testing
- CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
- Where
- 72 sites in Netherlands
- Volunteers
- 1,050 people
- Sponsor
- Borstkanker Onderzoek Groep
Healthy Volunteers
A Study of LY2835219 in Healthy Participants
Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food.
- Trial name
- NCT02059148
- Testing
- LY2835219
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Breast Cancer, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
Mesothelioma, Malignant
Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma
MiST is a British Lung Foundation funded, University of Leicester Study, a multi-arm stratified therapy based clinical trial for patients with relapsed mesothelioma.
- Trial name
- MiST (NCT03654833)
- Testing
- Rucaparib, Abemaciclib, pembrolizumab & bemcentinib
- Where
- United Kingdom
- Volunteers
- 186 people
- Sponsor
- University of Leicester
Breast Cancer Female
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy, chemotherapy, surgery), and who have to be identified with having a high risk of recurrence of cancer, will be eligible for the study.
- Trial name
- ADAPTlate (NCT04565054)
- Testing
- Abemaciclib 50 MG; 150mg 1-0-1 per os
- Where
- 85 sites in Germany, Poland and 1 more
- Volunteers
- 1,260 people
- Sponsor
- Women's Cancer Study Group GmbH