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Sponsors and Collaborators: |
University of Kansas Pfizer |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00328432 |
To assess the effects of short term administration of celecoxib 400 mg bid between biopsy and reexcision.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: celecoxib 400 mg bid |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IB Study of Biomarker Modulation by Celecoxib vs. Placebo in Women With Newly-Diagnosed Breast Cancer |
Estimated Enrollment: | 100 |
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.).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
US Oncology | |
Dallas, Texas, United States, 75246 |
Principal Investigator: | Carol J Fabian, MD | University of Kansas |
Study ID Numbers: | 9061 |
Study First Received: | May 19, 2006 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00328432 |
Health Authority: | United States: Institutional Review Board |
early breast cancer double-blind randomized placebo-controlled RCT pre-surgical model |
DCIS model COX-2 inhibitor celecoxib Ki-67 placebo |
Celecoxib Skin Diseases Breast Neoplasms Breast Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |