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Home > "B" Clinical Trials Conditions > Bexarotene in Preventing Breast Cancer in Women at Genetic Risk  Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Baylor College of Medicine , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Known carrier of a BRCA-1 or BRCA-2 mutation - Copy of laboratory report stating results must be available for review OR - At risk for carrying a BRCA-1 or BRCA-2 mutation - At least 10% risk by Parmigiana probability model - Must have at least 1 breast that has never been involved with cancer and has not been irradiated - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC greater than 4,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hematocrit greater than 30% Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 1.5 times ULN - Albumin no greater than 1.5 times ULN - No biliary tract disease Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study therapy - Triglycerides normal - Thyroid-stimulating hormone and thyroxine normal - Willing to undergo 2 duplicate needle biopsies of the breast - Willing to undergo genetic testing for BRCA-1 and BRCA-2 - No uncontrolled hyperlipidemia - No nontoxic goiter or thyroid enlargement - No severe underlying chronic illness or disease - No uncontrolled diabetes - No history of pancreatitis - No cancer within the past year except skin cancer or carcinoma in situ of the cervix (defined from the date of first diagnosis) - No concurrent alcohol use (greater than 3 drinks or its equivalent per day) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 1 year since prior chemotherapy for a neoplasm Endocrine therapy - More than 3 months since prior postmenopausal hormonal therapy (including estrogens or progestins) - More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators - No concurrent hormone replacement therapy - Concurrent thyroid hormone supplementation allowed Radiotherapy - See Disease Characteristics Surgery - Not specified Other - More than 30 days since prior investigational medications - More than 3 months since prior oral vitamin A supplements greater than the recommended daily requirement (5,000 IU) or therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin) - No concurrent participation in a study of an investigational agent - No concurrent medications known to be associated with pancreatic toxicity or to increase triglyceride levels
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardElledge, Study Chair, Baylor College of Medicine
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Banu Arun 713-792-2817
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Richard Elledge 713-798-1999
Cancer Therapy and Research Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Alexander Miller 210-562-1585
Additional Information:
Study ID Numbers: CDR0000271913; BCM-H-9315
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055991
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Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
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