Protocol for Women at Increased Risk of Developing Breast Cancer
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
1 other identifier
interventional
72
1 country
1
Brief Summary
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Apr 2003
Longer than P75 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
September 5, 2013
CompletedNovember 7, 2016
September 1, 2016
6.7 years
February 10, 2006
June 24, 2013
September 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
Immunocytochemical staining of breast epithelial cells. Positive cells reflect proliferative activity.
Baseline and 12 months
Secondary Outcomes (4)
Mammographic Breast Density
Baseline and 12 months
Serum Estradiol Concentration
Baseline to 12 months
Serum Sex Hormone Binding Globulin (SHBG) Concentration
Baseline to 12 months
Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3
baseline to 12 months
Study Arms (2)
1
ACTIVE COMPARATOROral Celecoxib 400 mg twice daily for 12 months
2
PLACEBO COMPARATORMatched blinded placebo twice daily for 12 months
Interventions
Eligibility Criteria
You may qualify if:
- women who have a high risk of breast cancer
- older than 18 years
You may not qualify if:
- anticoagulants
- marked breast tenderness
- pregnant or within twelve months of breast feeding/childbirth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carol Fabian, MDlead
- Susan G. Komen Breast Cancer Foundationcollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Carol Fabian
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Carol J Fabian, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Director Breast Cancer Prevention Unit
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 14, 2006
Study Start
April 1, 2003
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 7, 2016
Results First Posted
September 5, 2013
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share