|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Kansas Susan G. Komen Breast Cancer Foundation |
|---|---|
| Information provided by: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00291694 |
Purpose
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: celecoxib Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blinded Phase II Study of the Expression of Ki-67/MIB-1 in Women With Hyperplasia of the Breast Randomized to Receive Daily Celecoxib 400 mg BID or Placebo |
| Enrollment: | 72 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Celecoxib
|
Drug: celecoxib
Celecoxib 400 mg BID
|
|
2: Placebo Comparator
Placebo
|
Other: placebo
placebo
|
A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Carol J Fabian, MD | University of Kansas |
More Information
| Responsible Party: | University of Kansas Medical Center ( Carol Fabian ) |
| Study ID Numbers: | 9118 |
| Study First Received: | February 10, 2006 |
| Last Updated: | September 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00291694 |
| Health Authority: | United States: Institutional Review Board |
|
breast atypia double-blind randomized clinical trial RCT celecoxib COX-2 inhibitor |
placebo high risk for breast cancer breast epithelial hyperplasia ki-67 chemoprevention |
|
Hyperplasia 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 |
