Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Start Date
12/28/2023
Completion Date
11/1/2030
Summary
This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers
Detailed Description
Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Abemaciclib
Abemaciclib
Abemaciclib
Conditions
Locations
University of Illinois
Chicago, Illinois 60612
United States
Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States