celecoxib in treating postmenopausal women who are undergoing surgery for invasive breast cancer

Conditions: Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this randomized phase i trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at memorial sloan-kettering cancer center. celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

primary objectives: i. determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery. secondary objectives: i. correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (cox)-2 and her-2/neu and estrogen receptor status in these patients. ii. 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. iii. determine whether any observed biological effect of this drug is dose-dependent in these patients. iv. 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.

Eligibility criteria:
inclusion criteria: * 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 * female * postmenopausal as defined by at least 1 of the following: * no menstrual period within the past 12 months * prior bilateral oophorectomy * no known liver disease * no renal insufficiency * no congestive heart failure * no coronary artery disease * no history of documented peptic ulcer disease * no gastritis * 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 * more than 3 months since prior chemotherapy * 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 * 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