S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

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