Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT00070057
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:
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 patients.
III. Determine whether any observed biological effect of this drug is dose-dependent in these patients.
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.
Study:
NCT00070057
Study Brief:
Protocol Section:
NCT00070057