Sulindac and Breast Density in Women at Risk of Developing Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized Phase II Clinical Trial of Sulindac for Reducing Breast Density in Postmenopausal Women at Risk of Developing Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Sulindac Pill
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≤70 years Subject must be postmenopausal. Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable. Must have dense breasts Must be at elevated risk for developing breast cancer by abnormal pathological findings, family history, or genetic predisposition A negative fecal occult blood test Normal organ function Hormonal therapy with aromatase inhibitors is allowed Exclusion Criteria: Daily aspirin or other daily anti inflammatory use. Known intolerance to anti inflammatory. Use of any selective estrogen receptor modulator therapy (e.g., tamoxifen, raloxifene) within past 12 months Gastrointestinal, bleeding or coagulation, cardiovascular disorders. Diabetes requiring insulin therapy. Current regular smoker. History of claustrophobia or inability to undergo imaging in a closed magnetic resonance imaging. Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI. Uncontrolled hypertension.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sulindac<br>sulindac 150 mg | Drug: Sulindac Pill<br>* Randomized participants will receive either 150 mg oral sulindac twice daily.<br>|
| Placebo Comparator: Placebo<br>placebo pill | Drug: Placebo<br>* placebo pills twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent breast density by MRI |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in collagen type in breast tissue by whole slide mass spectrometry of tissue biopsy |  | 6 months | 
| Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Density