Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	MSKCC-03027 NCT00070057, N01-CN-35112

Objectives

Primary

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

Secondary

1. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.
2. 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 PGE₂ levels in these patients.
3. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
4. Identify collateral targets (COX-2-independent) of this drug in these patients.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Elisa Rush Port, MD, Principal investigator		Ph: 212-639-5461; 800-525-2225 Email: porte@mskcc.org
Clifford Hudis, MD, Principal investigator		Ph: 646-888-4551; 800-525-2225

Registry Information
Official Title		A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer
Trial Start Date		2003-04-08
Registered in ClinicalTrials.gov		NCT00070057
Date Submitted to PDQ		2003-08-12
Information Last Verified		2005-04-06
NCI Grant/Contract Number		CA08748, CN-35112

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