A Multicenter Randomized Double-Blind Trial Of Targretin Capsules Modifying Immunophenotypic Markers Related To Breast Cancer Progression In Breast Tissue From Genetically Identified High Risk Patients
- Determine whether bexarotene can modify immunophenotypic markers related to breast
cancer progression in women at high genetic risk for breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to menopausal status (women with a uterus who have not had a
menstrual period for more than 1 year vs any woman over 55 years old vs women 55 years and
under without a uterus whose follicle-stimulating hormone is in the postmenopausal range).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral bexarotene once daily on days 1-28.
- Arm II: Patients receive oral placebo as in arm I. In both arms, treatment continues in
the absence of unacceptable toxicity or elevation of triglycerides to greater than 800
mg/dL. Patients undergo 2 breast biopsies in the same location on days 1 and 29.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this
study within 4 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Chemopreventive effect as determine by a modification of the immunophenotypic characteristics of normal breast tissue at day 29 during study treatment and day 30 after study completion
Richard M. Elledge, MD
Baylor College of Medicine
United States: Food and Drug Administration
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|
|Dan L. Duncan Cancer Center at Baylor College of Medicine||Houston, Texas 77030|