Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer
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.).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Proliferation marker (Ki-67) in tissue specimens comparing baseline and post-drug administration specimens.
Carol J Fabian, MD
University of Kansas
United States: Institutional Review Board
|Loyola University Medical Center||Maywood, Illinois 60153|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|The Ohio State University||Columbus, Ohio 43210|
|University Of Alabama-Birmingham||Birmingham, Alabama 35294|
|US Oncology||Houston, Texas 77060|
|MDDesert Comprehensive Breast Center||Palm Springs, California 92262|
|Cleveland Clinical Foundation||Cleveland, Ohio 44195|