Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Iowa
Iowa Holden Comprehensive Cancer Center
RECRUITING
Iowa City
Illinois
University of Illinois
RECRUITING
Chicago
Contact Information
Primary
Mercedes Carrasquillo, MPH
micarras@uic.edu
312-413-1902
Backup
VK Gadi, MD
vkgadi@uic.edu
312-4135309
Time Frame
Start Date: 2023-12-28
Estimated Completion Date: 2030-11
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov

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