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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
NCT06169371 · University of Illinois at Chicago
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 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
In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84
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
Study design
Enrollment target: 50 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-28
Estimated completion: 2030-11
Last updated: 2026-01-14
Interventions
Drug: AbemaciclibDrug: AbemaciclibDrug: Abemaciclib
Primary outcomes
- • Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 (Day 84)
Sponsor
University of Illinois at Chicago · other
Contacts & investigators
ContactMichelle Karan · contact · makaran2@uic.edu · 224-563-7137
ContactVK Gadi, MD, PhD · contact · vkgadi@uic.edu · 312-4135309
InvestigatorVK Gadi, MD, PhD · principal_investigator, University of Illinois at Chicago
All locations (3)
University of IllinoisRecruiting
Chicago, Illinois, United States
Iowa Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States