| Original Study ID : CDR0000329919 |
| Secondary ID : MSKCC-03027 |
| NCT ID : NCT00070057 |
| Brief Title : Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer |
| Official Title : A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer |
| Brief Summary : RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : 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. |
| Overall Status : Active, not recruiting |
| Start Date : April 2003 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Active Control |
| Verification Date : April 2005 |
| First Received Date : October 3, 2003 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Memorial Sloan-Kettering Cancer Center |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : New York Weill Cornell Cancer Center at Cornell University |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Type : Procedure |
| Name : conventional surgery |
| Type : Procedure |
| Name : neoadjuvant therapy |
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