NCT06169371

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Abemaciclib	Week 1 50mg orally BID
DRUG	Abemaciclib	Week 2 100mg orally BID
DRUG	Abemaciclib	Week 3+ 150mg orally BID

Timeline

• Start date: 2023-12-28
• Primary completion: 2030-11-01
• Completion: 2030-11-01
• First posted: 2023-12-13
• Last updated: 2026-01-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study