Spots Global Cancer Trial Database for Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
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Trial Identification
Brief Title: Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor 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
Study ID: NCT05467891
Study Description
Brief Summary: 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.
Detailed Description: Collection of Correlative Samples at First Recurrence (Stage I consent) If feasible, optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence. Patients should then complete radiation therapy if that is indicated. Enrollment to the Treatment Phase will occur within 6 months of the last local treatment, surgery or radiation treatment, whichever occurred last. Study Treatment (Stage II/ main consent) Treatment includes: 1. Ribociclib: Oral ribociclib at a dose of 600 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice. 2. Physician's Choice Endocrine Therapy: ET consists of one of the following: * Intramuscular fulvestrant * Oral anastrozole * Oral letrozole * Oral exemestane * Concomitant use with tamoxifen is not allowed. Ribociclib administration is planned for 36 months and ET administration is planned for 60 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Arizona, Phoenix, Arizona, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Parkview Research Center, Fort Wayne, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
University of Michigan Health-West, Wyoming, Michigan, United States
University of Michigan Health-West, Wyoming, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York University Clinical Cancer Center, New York, New York, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Penn State Cancer Institute, Hershey, Pennsylvania, United States
University of Virginia Health System, Charlottesville, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Contact Details
Name: Oana Danciu, MD
Affiliation: University of Illinois at Chicago
Role: PRINCIPAL_INVESTIGATOR
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