RECRUITING

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

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 an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Official Title

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Quick Facts

Study Start:2022-09-13
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05467891

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Oana Danciu, MD
CONTACT
312-996-1581
ocdanciu@uic.edu
Rebecca Mottier
CONTACT
317-634-5842
rmottier@hoosiercancer.org

Principal Investigator

Oana Danciu, MD
PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Arizona
Phoenix, Arizona, 85004
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
University of Illinois Cancer Center
Chicago, Illinois, 60612
United States
Parkview Research Center
Fort Wayne, Indiana, 46845
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
University of Michigan Health-West
Wyoming, Michigan, 49519
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
New York University Clinical Cancer Center
New York, New York, 10016
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States
University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Oana Danciu

  • Oana Danciu, MD, PRINCIPAL_INVESTIGATOR, 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 Date2022-09-13
Study Completion Date2027-12

Study Record Updates

Study Start Date2022-09-13
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Locoregional Recurrence
  • Hormone Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer