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Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Trial Status: active
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
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06169371.
Locations matching your search criteria
United States
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
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
