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.
I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with
invasive breast cancer planning to undergo surgery.
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
III. Determine whether any observed biological effect of this drug is dose-dependent in
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.
- 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
- 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
- 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