S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

DISEASE CHARACTERISTICS:

• At elevated risk of developing breast cancer, as defined by 1 of the following:

  • Modified Gail risk at 5 years ≥ 1.7% or lifetime risk ≥ 20% AND Claus Model, BRCAPro Model, or Tyrer-Cuzick Model lifetime risk ≥ 20%
  • Diagnosis of lobular carcinoma in situ or ductal carcinoma in situ
  • Known deleterious mutation of BRCA1 or BRCA2
• At least 1 breast available for imagery and biopsy

• Has undergone a baseline mammogram with a standard density wedge within 7-14 days after completion of the last menstrual period AND within 7 days before study entry

  • Mammogram normal or benign (BIRADS score 0 or 1)

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Premenopausal, defined by 1 of the following criteria:

  • Last menstrual period < 6 months ago AND no prior bilateral ovariectomy AND not on estrogen replacement therapy
  • Prior hysterectomy (with ovaries still in place) AND normal follicle-stimulating hormone levels within 28 days of study entry

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin < 2.0 times institutional upper limit of normal (IULN)
• SGOT or SGPT < 2 times IULN
• Alkaline phosphatase < 2 times IULN
• INR ≤ 1.5
• PT and PTT ≤ IULN

Renal

• Serum creatinine < 2.0 times IULN

Cardiovascular

• No history of myocardial infarction
• No angina pectoris
• No known coronary artery disease
• No history of stroke or mini-stroke (e.g., transient ischemic attack)
• No history of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)
• No uncontrolled hypertension (i.e., blood pressure > 140/90 mmHg)

Pulmonary

• No asthma after taking aspirin or other NSAIDs

Other

• No known sensitivity to celecoxib
• No allergy to sulfonamides
• No urticaria or allergic-type reactions after taking aspirin or other NSAIDs
• No extreme lactose intolerance
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or early bladder cancer (preinvasive transitional cell carcinoma of the bladder)
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 5 years since prior biologic therapy for cancer

Chemotherapy

• More than 5 years since prior chemotherapy for cancer

Endocrine therapy

• At least 28 days since prior tamoxifen
• No prior systemic estrogen modifiers (SERMs) or aromatase inhibitors
• Concurrent hormonal contraception (i.e., pills, patches, or shots) allowed provided contraception was initiated prior to study entry

Radiotherapy

• No prior radiotherapy to the breast to be studied

Surgery

• Not specified

Other

• At least 7 days since prior anticoagulant therapy

• More than 1 month since prior chronic daily aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) of more than 7 days duration

  • Concurrent intermittent aspirin or NSAIDs allowed (no more than 10 days per month)
• No concurrent participation in another clinical trial for treatment or prevention of cancer unless no longer receiving treatment and is in the follow-up phase