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 prov
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 s |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Illinois at Chicago |
| Locations | Chicago, Illinois, United States; Iowa City, Iowa, United States; Columbus, Ohio, United States |
| Start date | 2023-12-28 |
| NCT ID | NCT06169371 |
| Official listing | https://clinicaltrials.gov/study/NCT06169371 |