Clinical trial · Interventional
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
NCT00291694CI-TRIAL-00024737completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Oral Celecoxib 400 mg twice daily for 12 months
- interventionNames
- Drug: celecoxib
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Matched blinded placebo twice daily for 12 months
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Change in Percent of Breast Epithelial Cells Staining Positive for Ki-67
- timeFrame
- Baseline and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.