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Abemaciclib Dose Escalation for Early-Stage Breast Cancer

This study is for people aged 18 or older with early-stage, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer. It's testing a new way to give abemaciclib, a drug used with hormone therapy (ET). Instead of starting at the full dose, participants will gradually increase their abemaciclib dose over a few weeks (50mg, then 100mg, then 150mg twice daily). The goal is to see if this gradual increase helps more people stay on the full dose of abemaciclib by day 84 by reducing side effects like severe diarrhea. This study plans to enroll 50 participants, but its current recruitment status is unclear.

Study design
This is a single-arm, phase IV study, meaning all participants will receive the same treatment. It aims to enroll 50 participants.
What's involved
Participants will take abemaciclib orally twice a day, with the dose increasing over the first three weeks. After the study intervention, participants will continue on abemaciclib and endocrine therapy as decided by their doctors.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at day 84, after which participants will continue treatment at their doctor's discretion.

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NCT06169371

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Illinois at Chicago
~50 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Abemaciclib

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
Measured over Day 84

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

3 sites across 3 states
Illinois1
Iowa1
Ohio1

Study leadership

  • VK Gadi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Michelle Karan
[email protected]
224-563-7137
Email the study team

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Eligibility criteria

Inclusion

ECOG 0-2
Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion

Chronic history of diarrhea
Active infection requiring systemic therapy
Uncontrolled HIV/AIDS or active viral hepatitis
Pregnant or nursing
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
Other major comorbidity as determined by study PI

What this trial measures

  • Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84Day 84

    Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days