S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: celecoxib; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: breast cancer; breast cancer in situ; lobular breast carcinoma in situ; ductal breast carcinoma

Summary:

      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. The use of celecoxib may be effective in preventing
      breast cancer.

      PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing
      breast cancer in premenopausal women who are at risk for developing the disease.
    

Eligibility 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