Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) (BRE-09)

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Abemaciclib; Drug: Abemaciclib; Drug: Abemaciclib; Drug: Abemaciclib

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 3-4 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: VK Gadi, MD; Phone Number: 312-4135309; Email: vkgadi@uic.edu
• Study Contact Backup: Name: Mercedes Carrasquillo, MPH; Phone Number: 312-413-1902; Email: micarras@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois
      • Contact: Mercedes Carrasquillo, MPH; Phone Number: 312-413-1902; Email: micarras@uic.edu
      • Contact: VK Gadi, MD; Phone Number: 3124135309; Email: vkgadi@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2023
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-0433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No