A Study of Women With an Early Diagnosis of Breast Cancer, Taking Celecoxib Between the Biopsy and Lumpectomy/Mastectomy
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer|
- Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
- Baseline and post-administration assessments of MAP kinase, pERK1 and 2, activated pAKT, change in apotosis indicators, and angiogenesis associated proteins, and Her-2/neu.
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||December 2005|
A double blind randomized study of celecoxib 400 mg bid versus placebo in newly diagnosed breast cancer. Assessment of modulation of tissue markers (Ki-67, ER, VEGF, PR, etc.) and serum markers (estradiol, estrone, SHBG, etc.).
|United States, Alabama|
|University of Alabama-Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|MDDesert Comprehensive Breast Center|
|Palm Springs, California, United States, 92262|
|United States, Illinois|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Ohio|
|Cleveland Clinical Foundation|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Carol J Fabian, MD||University of Kansas|