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
18 Years
N/A
Female
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Richard M. Elledge, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000271913
NCT ID:
NCT00055991
Start Date:
September 2001
Completion Date:
September 2006
Related Keywords:
- Breast Cancer
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
