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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Celecoxib

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