Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Meets 1 of the following criteria:
• •* Gail assessment score \> 1.7% risk for 5 years
• •* History of lobular carcinoma in situ (pathology report required)
• •* History of ductal carcinoma in situ (DCIS) (pathology report required)
• •* History of breast cancer in ≥ 1 first-degree relative or history of BRCA1 or BRCA2 positivity not treated with oophorectomy or mastectomy (test report required)
• •* History of breast cancer in ≥ 2 second-degree relatives
• •* Any family history of breast cancer diagnosed prior to age 50
• •* Personal history of breast cancer (invasive or DCIS) with 1 breast intact
• •Nipple aspirate fluid production ≥ 5 microliters
• •Negative mammogram for breast cancer within the past 10 months
• •* Any suspicious breast masses must be examined by a clinical professional
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Sex
• •Female
• •Menopausal status
• •Pre- or postmenopausal
• •Performance status
• •Karnofsky 80-100%
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC ≥ 3,000/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •No history of bleeding or clotting disorder
• •Hepatic
• •Bilirubin ≤ 2.0 mg/dL
• •AST and ALT ≤ 2.0 times upper limit of normal
• •No indication of abnormal liver function
• •Renal
• •Creatinine normal
• •Cardiovascular
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Gastrointestinal
• •No frequent, chronic, or moderate/severe gastric complaint
• •No upper gastrointestinal problems (e.g., symptoms of heartburn, dyspepsia, or abdominal pain) requiring prescription or nonprescription medical remedies more than once per week (on average)
• •No history of peptic ulcer or occult or gross intestinal bleeding
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No history of allergic reaction (e.g., urticaria, asthma, rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
• •No history of allergy attributed to lidocaine, EMLA® cream, or xylocaine
• •No concurrent uncontrolled illness
• •No ongoing or active infection
• •No psychiatric illness or social situation that would preclude study compliance
• •No more than 2-3 servings of alcohol per week during study participation
• •PRIOR CONCURRENT THERAPY:
• •Chemotherapy
• •More than 6 months since prior chemotherapy for breast cancer (invasive or DCIS)
• •Endocrine therapy
• •More than 6 months since prior hormonal therapy for breast cancer (invasive or DCIS)
• •No concurrent hormone-suppressing agents (e.g., tamoxifen or anastrozole)
• •No concurrent selective estrogen-receptor modulators
• •No concurrent aromatase inhibitors
• •Radiotherapy
• •More than 6 months since prior radiotherapy for breast cancer (invasive or DCIS)
• •Surgery
• •See Disease Characteristics
• •No prior breast duct-disrupting surgery (e.g., mastectomy) that would preclude ductoscopy
• •Other
• •More than 3 months since prior warfarin or other systemic anticoagulant
• •More than 4-6 weeks since prior nonsteroidal anti-inflammatory drugs
• •No concurrent phenytoin or sulfonamides
• •No concurrent warfarin or other systemic anticoagulant
• •No other concurrent nonsteroidal anti-inflammatory drugs (including low-dose aspirin)
• •No concurrent large doses of supplements, vitamins (\> regular daily multivitamin) and/or herbal medicines (e.g., echinacea, ginkgo biloba, Hypericum perforatum \[St. John's wort\], or herbal tea)
• •No other concurrent investigational agents