Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Phase 4

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06169371
• Lead Sponsor: University of Illinois at Chicago

Brief 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

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Study Start: 2023-12-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2030-11
• Study Completion: 2030-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84	Day 84	Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days

Secondary Outcome Measures

Name	Time	Method
Rate of Grade 3 or greater of diarrhea in the first 3 months	3 months	Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled
Disease Free Survival (DFS)	2 years	Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death
Overall Survival (OS)	3 years	OS is defined as the time from D1 of treatment until death
How many days with Grade 2 or greater of diarrhea in the first month	1 month	Number of days with Grade 2 or greater in the first month
Subject reported outcomes regarding adverse events	5 years	Toxicity grade as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Trial Locations

Locations (2)

Iowa Holden Comprehensive Cancer Center; 🇺🇸 Iowa City, Iowa, United States

University of Illinois; 🇺🇸 Chicago, Illinois, United States