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

Inclusion Criteria5

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 Criteria6

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