Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
University of Illinois at Chicago
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) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers
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 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 prot…
Interventions
- DrugAbemaciclib
Week 1 50mg orally BID
- DrugAbemaciclib
Week 2 100mg orally BID
- DrugAbemaciclib
Week 3+ 150mg orally BID
Locations (3)
- University of IllinoisChicago, Illinois
- Iowa Holden Comprehensive Cancer CenterIowa City, Iowa
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio