Recruiting

Abemaciclib & ETAbemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Sponsor:

University of Illinois at Chicago

Code:

NCT06169371

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abemaciclib

Study Details

Brief 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

Conditions

Breast Cancer

Study ID

NCT06169371

Start date

Dec 28, 2023

Status verified date

Jul, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single arm adjuvant abemaciclib

Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3.

Interventions

Abemaciclib

Week 1 50mg orally BID

Abemaciclib

Week 2 100mg orally BID

Abemaciclib

Week 3+ 150mg orally BID

Primary outcome measure

Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 [ Time Frame: Day 84 ]

Central Contacts and Locations

Central contacts

Michelle Karan

224-563-7137 makaran2@uic.edu

VK Gadi, MD, PhD

312-4135309 vkgadi@uic.edu

Locations

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Michelle Karan

224-563-7137 makaran2@uic.edu

VK Gadi, MD, PhD

312-413-5309 vkgadi@uic.edu

Iowa Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Sneha Phadke, DO

319-356-4200 sneha-phadke@uiowa.edu

Olivia Barritt

1-319-356-4200 Olivia-Barritt@uiowa.edu

Principal Investigator:

Sneha Phadke, DO

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Robert Wesolowski, MD

614-366-8541 Robert.Wesolowski@osumc.edu

Jenna Cody

800-293-5066 jenna.cody@osumc.edu

Principal Investigator:

Robert Wesolowski, MD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-07.