OBJECTIVES:

Primary

• Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.

Secondary

• Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
• Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients.
• Determine whether any observed biological effect of this drug is dose-dependent in these patients.
• Identify collateral targets (COX-2-independent) of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
• Arm II: Patients receive a higher dose of oral celecoxib as in arm I.
• Arm III: Patients do not receive treatment. All patients undergo definitive surgery.

PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast carcinoma

  • Tumor at least 1 cm by radiologic estimate or physical exam
  • No disease limited to ductal carcinoma in situ only
• Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• Over 18

Sex

• Female

Menopausal status

• Postmenopausal as defined by at least 1 of the following:

  • No menstrual period within the past 12 months
  • Prior bilateral oophorectomy

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No known liver disease

Renal

• No renal insufficiency

Cardiovascular

• No congestive heart failure
• No coronary artery disease

Gastrointestinal

• No history of documented peptic ulcer disease
• No gastritis

Other

• No medical condition that would preclude definitive surgery
• No allergy to NSAIDs or sulfa-containing drugs

• No connective tissue diseases, including any of the following:

  • Systemic lupus erythematosus
  • Reynaud's disease
  • Scleroderma

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 3 months since prior chemotherapy

Endocrine therapy

• More than 2 weeks since prior hormone replacement therapy
• More than 2 weeks since prior tamoxifen
• More than 2 weeks since prior aromatase inhibitors
• More than 2 weeks since prior raloxifene
• More than 2 weeks since prior steroids

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
• More than 1 week since prior cyclooxygenase (COX)-2 inhibitors
• No concurrent warfarin
• No concurrent thiazide or loop diuretics
• No concurrent COX-2 inhibitors
• No concurrent NSAIDs