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Protocol for Women at Increased Risk of Developing Breast Cancer

This study has been completed.
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute Identifier:
First received: February 10, 2006
Last updated: September 16, 2016
Last verified: September 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Carol Fabian, MD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 [ Time Frame: Baseline and 12 months ]
    Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.

Secondary Outcome Measures:
  • Mammographic Breast Density [ Time Frame: Baseline and 12 months ]
    The percent of mammographic breast area that is considered to be at increased density. Evaluated using the semi-automated computer program Cumulus.

  • Serum Estradiol Concentration [ Time Frame: Baseline to 12 months ]
    Change in serum estradiol concentration

  • Serum Sex Hormone Binding Globulin (SHBG) Concentration [ Time Frame: Baseline to 12 months ]
    Change in serum concentration

  • Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3 [ Time Frame: baseline to 12 months ]
    Change ion ratio.

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
Oral Celecoxib 400 mg twice daily for 12 months
Drug: celecoxib
Celecoxib 400 mg BID
Other Name: Celebrex
Placebo Comparator: 2
Matched blinded placebo twice daily for 12 months
Other: 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00291694

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
Principal Investigator: Carol J Fabian, MD University of Kansas Medical Center
  More Information

Responsible Party: Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center Research Institute Identifier: NCT00291694     History of Changes
Other Study ID Numbers: 9118
Study First Received: February 10, 2006
Results First Received: June 24, 2013
Last Updated: September 16, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Carol Fabian, MD, University of Kansas Medical Center Research Institute:
breast atypia
double-blind randomized clinical trial
COX-2 inhibitor
high risk for breast cancer
breast epithelial hyperplasia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2017