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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

RecruitingPhase 4

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: University of Illinois at Chicago · Participants: 50 · Started: Dec 28, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06169371

Locations in the U.S.

IllinoisUniversity of Illinois, Chicago
IowaIowa Holden Comprehensive Cancer Center, Iowa City
OhioOhio State University Comprehensive Cancer Center, Columbus

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.