Actively Recruiting
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Led by University of Illinois at Chicago · Updated on 2026-01-14
50
Participants Needed
3
Research Sites
357 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0 to 2
- Histologically confirmed early-stage hormone receptor-positive, HER2-negative breast cancer by biopsy
- Prescribed adjuvant abemaciclib treatment
- Able to provide written informed consent and HIPAA authorization
- Women of childbearing potential must have a negative pregnancy test and not be pregnant or breastfeeding
- Ability to understand and comply with study procedures for the entire study duration as determined by physician or designee
You will not qualify if you...
- Chronic history of diarrhea
- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Other major comorbidities as determined by the study principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Michelle Karan
CONTACT
V
VK Gadi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here