About this trial
This study is looking at how to use a medicine called abemaciclib for patients with early-stage hormone receptor positive, HER2 negative breast cancer. The goal is to help patients take the right dose of abemaciclib while reducing side effects like diarrhea. Participants will receive abemaciclib along with other hormone treatments and may continue this combination after the study ends.
The trial's ID number is NCT06169371. It is a Phase 4 study, which means it is looking at how well the treatment works and its safety. The trial is regulated by the FDA, and it aims to include about 50 participants.
Who can join
This trial is open to adults ages 18 and older, including men and women with early-stage breast cancer. Participants must be able to give consent and should not be pregnant or breastfeeding. Some medical conditions may prevent people from joining, but the trial team will confirm eligibility.
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Everyone in the trial will take abemaciclib, starting with a low dose that increases over time. They will take 50 mg twice a day for the first week, 100 mg twice a day for the second week, and 150 mg twice a day from the third week onward. This gradual increase helps to manage side effects.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.
Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa
Ohio State University Comprehensive Cancer Center
Columbus, Ohio
University of Illinois
Chicago, Illinois