RECRUITING

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Quick Facts

Study Start:2023-12-28
Study Completion:2030-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06169371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ECOG 0-2
  2. * Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
  3. * 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.
  4. * Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
  5. * 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.
  1. * Chronic history of diarrhea
  2. * Active infection requiring systemic therapy
  3. * Uncontrolled HIV/AIDS or active viral hepatitis
  4. * Pregnant or nursing
  5. * 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.
  6. * Other major comorbidity as determined by study PI

Contacts and Locations

Study Contact

Mercedes Carrasquillo, MPH
CONTACT
312-413-1902
micarras@uic.edu
VK Gadi, MD
CONTACT
312-4135309
vkgadi@uic.edu

Study Locations (Sites)

University of Illinois
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-28
Study Completion Date2030-11

Study Record Updates

Study Start Date2023-12-28
Study Completion Date2030-11

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer