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Protocol for Women at Increased Risk of Developing Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00291694
First received: February 10, 2006
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Cytology of breast tissue aspirate using standard scoring methods and the Masood scoring system. [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum markers for hormones and growth factors, mammographic breast density [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2003
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Celecoxib
 Drug: celecoxib
Celecoxib 400 mg BID
Other Name: Celebrex
Placebo Comparator: 2
Placebo
 Other: placebo
placebo
Other Name: placebo

Detailed Description:

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
Criteria

Inclusion Criteria:

  • women who have a high risk of breast cancer
  • older than 18 years

Exclusion Criteria:

  • anticoagulants
  • marked breast tenderness
  • pregnant or within twelve months of breast feeding/childbirth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291694

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Fabian, MD
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Carol J Fabian, MD University of Kansas
  More Information

No publications provided

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00291694     History of Changes
Other Study ID Numbers: 9118
Study First Received: February 10, 2006
Last Updated: February 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
breast atypia
double-blind randomized clinical trial
RCT
celecoxib
COX-2 inhibitor
 placebo
high risk for breast cancer
breast epithelial hyperplasia
ki-67
chemoprevention

Additional relevant MeSH terms:
Breast Neoplasms
Hyperplasia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pathologic Processes
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013