RecruitingPhase 4NCT06169371

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Sponsor

University of Illinois at Chicago

Enrollment

50 participants

Start Date

Dec 28, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether gradually increasing the dose of abemaciclib (a drug used after surgery for early-stage hormone receptor-positive, HER2-negative breast cancer) can reduce the common side effect of diarrhea while still keeping the treatment effective. **You may be eligible if...** - You have early-stage hormone receptor-positive, HER2-negative breast cancer confirmed by biopsy - Your doctor has prescribed abemaciclib as part of your after-surgery treatment - You are not pregnant or breastfeeding - You are in generally good health (ECOG 0-2) **You may NOT be eligible if...** - You have a history of chronic diarrhea - You have an active infection requiring treatment - You have uncontrolled HIV/AIDS or active hepatitis - You are pregnant or nursing - You have another cancer that could interfere with this treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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