Using abemaciclib with endocrine therapy for early-stage breast cancer
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
PHASE4 · University of Illinois at Chicago · NCT06169371
This study is testing if a new way of giving abemaciclib with hormone therapy can help people with high-risk early-stage breast cancer avoid severe side effects and stay on their treatment longer.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago (other) |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT06169371 on ClinicalTrials.gov |
What this trial studies
This phase IV trial investigates the use of abemaciclib in combination with endocrine therapy for patients with high-risk early-stage HR+HER2- breast cancer. The study aims to gradually increase the dose of abemaciclib over 2-3 weeks to reduce the incidence of severe diarrhea, allowing more patients to maintain the intended dosage. Participants will continue the combination therapy at the discretion of their healthcare providers after the intervention period. The trial is designed to assess the tolerability and effectiveness of this dosing strategy.
Who should consider this trial
Good fit: Ideal candidates are women with histologically confirmed early-stage HR+HER2- breast cancer who are prescribed adjuvant abemaciclib.
Not a fit: Patients with a chronic history of diarrhea or those with active infections requiring systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the tolerability of abemaciclib, allowing more patients to benefit from effective treatment.
How similar studies have performed: Previous studies have shown that dose escalation can improve tolerability for similar treatments, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 2 other locations
- University of Illinois — Chicago, Illinois, United States (RECRUITING)
- Iowa Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (RECRUITING)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: VK Gadi, MD, PhD — University of Illinois at Chicago
- Study coordinator: Michelle Karan
- Email: makaran2@uic.edu
- Phone: 224-563-7137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer