Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Purpose

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

Condition

  • Breast Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Single arm adjuvant abemaciclib 		Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3.
  • Drug: Abemaciclib
    Week 1 50mg orally BID
  • Drug: Abemaciclib
    Week 2 100mg orally BID
  • Drug: Abemaciclib
    Week 3+ 150mg orally BID

Recruiting Locations

University of Illinois
Chicago, Illinois 60612
Contact:
Michelle Karan
224-563-7137
makaran2@uic.edu

Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Contact:
Sneha Phadke, DO
319-356-4200
sneha-phadke@uiowa.edu

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Robert Wesolowski, MD
614-366-8541
Robert.Wesolowski@osumc.edu

More Details

Status
Recruiting
Sponsor
University of Illinois at Chicago

Study Contact

Michelle Karan
224-563-7137
makaran2@uic.edu

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