Phase 2
N=72
Protocol for Women at Increased Risk of Developing Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00291694 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 — -1.2; -2.0 percentage of cells staining positive — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- celecoxib (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Carol Fabian, MD
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67 |
-1.2; -2.0 | 0.71 |
| SECONDARY Mammographic Breast Density |
-1.3; 0.3 | 0.053 |
| SECONDARY Serum Estradiol Concentration |
-6.6; -5.7 | 0.37 |
| SECONDARY Serum Sex Hormone Binding Globulin (SHBG) Concentration |
-0.70; 3.05 | 0.39 |
| SECONDARY Molecular Ratio of Serum Concentration of IGF-1 to IGFBP3 |
-0.012; -0.011 | 0.37 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00291694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.