Clinical trial · Interventional
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
NCT06169371CI-TRIAL-00117091BRE-09recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm adjuvant abemaciclib
- description
- Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3.
- interventionNames
- Drug: Abemaciclib
Primary outcomes (1)
- measure
- Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
- timeFrame
- Day 84
- description
- Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days
Secondary outcomes (8)
- measure
- How many days with Grade 2 or greater of diarrhea in the first month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.