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.).
Interventional
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
Principal Investigator
University of Kansas
United States: Institutional Review Board
9061
NCT00328432
June 2003
December 2005
Name | Location |
---|---|
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 |