S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

Inclusion Criteria

• •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