Clinical Trial

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Study acronym: BRE-09
Recruiting Phase 4
View on ClinicalTrials.gov →
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
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-12-05; most recent amendment 2026-07-04.
Status change: Not Yet Recruiting → Recruiting 2023-12-15
Trial Details
NCT Number NCT06169371
Lead Sponsor University of Illinois at Chicago
Conditions Breast Cancer
Enrollment 50 participants
Start Date 2023-12-28
Primary Completion 2030-11 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-07