Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Breast Cancer Clinical Trial

— BRE-09  

Official title:

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169371
• Other study ID #: 2023-0433
• Status: Recruiting
• Phase: Phase 4
• Start date: December 28, 2023
• Est. completion date: November 2030

Study information

• Verified date: January 2024
• Source: University of Illinois at Chicago
• Contact: Mercedes Carrasquillo, MPH
• Phone: 312-413-1902
• Email: micarras[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2030
• Est. primary completion date: November 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Abemaciclib
Week 1 50mg orally BID
• Abemaciclib
Week 2 100mg orally BID
• Abemaciclib
Week 3 150mg orally QAM, 100mg orally QHS
• Abemaciclib
Week 4 150mg orally BID

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	OS is defined as the time from D1 of treatment until death	1 year
Secondary	Overall Survival (OS)	OS is defined as the time from D1 of treatment until death	2 years
Secondary	Overall Survival (OS)	OS is defined as the time from D1 of treatment until death	3 years
Secondary	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