A Study to Identify Biomarker Modulation by a Cyclooxygenase-2 (COX-2) Inhibitor in Breast Tissue of Premenopausal Women at High Risk for Estrogen Receptor Negative (ERN) Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Increased risk for breast cancer on the basis of at least 1 of the following
criteria:

- Five-year Gail risk at least 1.7% or a calculated risk at least 5 times the
average for age group

- 20-29 years old - calculated 5-year Gail risk is at least 0.1%

- 30-39 years old - calculated 5-year Gail risk is at least 1.0%

- 40 and over - calculated 5-year Gail risk is at least 1.7%

- Known BRCA1/BRCA2 mutation carrier

- Family history consistent with hereditary breast cancer, as defined by any of
the following circumstances:

- At least 4 relatives with breast cancer at any age

- At least 2 first-degree relatives diagnosed with breast cancer at age 50 or
younger

- Breast and ovarian cancer diagnosed in the same relative

- At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer
at any age in the same family

- Prior biopsy exhibiting atypical hyperplasia, lobular cancer in situ, ductal
carcinoma in situ (DCIS)*, or invasive cancer** NOTE: *If DCIS or T1a or T1b
disease was found, at least 2 months must have elapsed since prior surgery
and/or radiotherapy to the involved breast

NOTE: **Prior invasive cancer (T1c, T2, or T3) must have been diagnosed at least 2 years
before study and be estrogen receptor-negative, node negative

- Must have had a random periareolar fine needle aspiration successfully performed
within the past 3 months, with at least 1,000 cells on cytology slide and 3
additional slides for biomarker analysis (1 with at least 500 cells for Ki-67 and 2
with at least 100 ductal cells for estrogen receptors and COX-2)

- Hormone receptor status:

- Estrogen receptor negative

PATIENT CHARACTERISTICS:

Age

- 18 to 55

Sex

- Female

Menopausal status

- Premenopausal, defined as menstrual periods estimated to occur every 21 to 35 days
over the past 6 months

Performance status

- Not specified

Life expectancy

- At least 5 years

Hematopoietic

- Absolute granulocyte count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

- No bleeding diathesis within the past year

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- Albumin at least 3.0 g/dL

- AST and ALT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- No severe liver disease requiring treatment

Renal

- Creatinine no greater than 1.5 mg/dL

Cardiovascular

- No high blood pressure not controlled by medication

- No history of angina

- No history of cardiovascular disease

- No history of deep vein thrombosis

Pulmonary

- No history of pulmonary embolism

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergy to sulfa, COX-2 inhibitors, or nonsteroidal anti-inflammatory drugs
(NSAIDs)

- No history of an ulcer requiring treatment

- No history of ulcerative colitis

- No inflammatory bowel disease

- No body mass index > 33

- No history of diabetes

- No prior metastatic malignancy of any kind

- No complications of alcoholism requiring hospitalization

- No concurrent asthma being treated

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 6 months since prior chemotherapy

Endocrine therapy

- At least 6 months since prior antihormone therapy (e.g., selective estrogen-receptor
modulators or aromatase inhibitors)

- Anticipated use of oral or IV corticosteroids must be less than 2 weeks per year

- No change (stop or start) in hormonal therapy within the past 6 months (e.g.,
estrogen, progesterone, oral contraceptives, or fertility agents)

Radiotherapy

- See Disease Characteristics

- No prior radiotherapy to the contralateral breast involved in the study treatment

Surgery

- See Disease Characteristics

Other

- At least 3 weeks since prior aspirin, rofecoxib, celecoxib, other COX-2 inhibitors,
or NSAIDs

- No concurrent anticoagulants

- No other concurrent NSAIDs

- No chronic angiotensin-converting enzyme inhibitors

- No chronic furosemide*

- No chronic fluconazole*

- No chronic lithium NOTE: *Occasional concurrent use allowed