RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Randomized phase I trial to study the effectiveness of celecoxib in treating postmenopausal women who have invasive breast cancer and are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center.

Condition	Treatment or Intervention	Phase
stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer	Drug: celecoxib  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: aromatase inhibition  Procedure: biological response modifier therapy  Procedure: conventional surgery  Procedure: endocrine therapy  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy  Procedure: hormone therapy  Procedure: neoadjuvant therapy  Procedure: surgery	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States

Study chairs or principal investigators

Elisa Rush Port, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   
Clifford A. Hudis, MD,  Principal Investigator,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000329919; MSKCC-03027; NCT00070057
Record last reviewed:  February 2005
Last Updated:  February 24, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00070057
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08