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NCT06169371
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
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
Trial Details
NCT ID NCT06169371 Phase PHASE4
Sponsor University of Illinois at Chicago
Status RECRUITING
Cancer Type Breast Cancer
Interventions Locations (sample) Chicago, Illinois, United States|41.85003,-87.65005 Iowa City, Iowa, United States|41.66113,-91.53017 Columbus, Ohio, United States|39.96118,-82.99879
Key Eligibility Criteria
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 Revi… Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional prac… As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedu… For full eligibility, visit ClinicalTrials.gov .
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