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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

NCT06169371•University of Illinois at Chicago

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (3)

University of Illinois

Chicago, Illinois, United States

Iowa Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

December 28, 2023

Primary Completion Date

November 1, 2030

Completion Date

November 1, 2030

Last Updated

January 14, 2026

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Abemaciclib

DRUG

Abemaciclib

DRUG

Abemaciclib

DRUG

Contacts

Michelle Karan

CONTACT

224-563-7137 makaran2@uic.edu

VK Gadi, MD, PhD

CONTACT

312-4135309 vkgadi@uic.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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