Clinical trial · Interventional
NSAID Effects on Clinical and Imaging Breast Biomarkers
NCT01761877CI-TRIAL-00063836completedPhase 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)
This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hypertension | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sulindac | Drug | Sulindac | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sulindac (Clinoril)
- description
- Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will receive 150 mg of sulindac twice daily for 12 months. They will receive up to 4 MRI within 12 months.
- interventionNames
- Drug: Sulindac
- type
- NO_INTERVENTION
- label
- Observational
- description
- Women taking aromatase inhibitors for adjuvant therapy for their breast cancer will continue their treatment will be monitored with MRI and standard of care tests every 6 months for up to 12 months.
Primary outcomes (1)
- measure
- Change in Breast Density Measured as Fat to Water Ratio by Magnetic Resonance Imaging
- timeFrame
- Baseline and 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months * Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months * Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of \> 25% as measured by standard digital mammography (BIRADs score \> 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study * A willingness to follow the study protocol, as indicated by provision of informed consent to participate * A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted) * Normal renal function as determined by a serum creatinine \< upper limit of normal * No known contraindication to NSAID use * Normotensive or controlled blood pressure (\< 140/90) on a single anti-hypertensive medication Exclusion Criteria: * Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection * Known intolerance to NSAIDs * Age \> 75 years * History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA) * Diabetes requiring drug therapy * Current smoker * History of Uncontrolled hypertension * Blood pressure \> 140/90 at baseline by home monitoring * History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years * History of a bleeding diathesis or current anticoagulant therapy * Daily therapy with H2 blockers or protein pump inhibitors * History of claustrophobia * Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
References
Publications (1)
- DERIVEDMartinez JA, Wertheim BC, Roe DJ, Chalasani P, Cohen J, Baer L, Chow HS, Stopeck AT, Thompson PA. Sulindac Improves Stiffness and Quality of Life in Women Taking Aromatase Inhibitors for Breast Cancer. Breast Cancer Res Treat. 2022 Feb;192(1):113-122. doi: 10.1007/s10549-021-06485-0. Epub 2022 Jan 18. PMID 35039952