Clinical trial · Interventional
Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer
NCT04542135CI-TRIAL-00118508completedPhase 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)
The primary objective of this study is to determine if sulindac at a dose of 150 mg twice a day for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control.
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 |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Sulindac Pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sulindac
- description
- sulindac 150 mg
- interventionNames
- Drug: Sulindac Pill
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo pill
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in Percent Breast Density by MRI Between Treatment Arms
- timeFrame
- 12 months
- description
- The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≤70 years 2. Subject must be postmenopausal. 3. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable. 4. Must have dense breasts 5. Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition 6. A negative fecal occult blood test 7. Normal organ function 8. Hormonal therapy with aromatase inhibitors is allowed Exclusion Criteria: 1. Daily aspirin or other daily anti inflammatory use. 2. Known intolerance to anti inflammatory. 3. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months 4. Gastrointestinal, bleeding or coagulation, cardiovascular disorders. 5. Diabetes requiring insulin therapy. 6. Current regular smoker. 7. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging. 8. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI. 9. Uncontrolled hypertension.
References
Publications (0)
Data not yet available
No reference posted for this study.