Phase IB Sulindac Study for 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