Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
- Registration Number
- NCT00055991
- Lead Sponsor
- Baylor Breast Care Center
- Brief Summary
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether bexarotene is effective in preventing breast cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of bexarotene in preventing breast cancer in women who are at genetic risk of developing breast cancer.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bexarotene bexarotene Bexarotene / Targretin Sugar Pill bexarotene Sugar pill / placebo
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Apoptosis at day 29 during study treatment
Trial Locations
- Locations (4)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Dan L. Duncan Cancer Center at Baylor College of Medicine
🇺🇸Houston, Texas, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States