Status:
RECRUITING
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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) Aft...
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 sin...
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
Key Trial Info
Start Date :
December 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06169371
Start Date
December 28 2023
End Date
November 1 2030
Last Update
March 27 2025
Active Locations (2)
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1
University of Illinois
Chicago, Illinois, United States, 60612
2
Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242