Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor Breast Care Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bexarotene

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