CompletedPhase 2

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

United States62 participantsStarted 2020-11-20

Plain-language summary

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.

Who can participate

Age range35 Years – 70 Years

SexFEMALE

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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.

What they're measuring

Change in percent breast density by MRI between treatment arms

Timeframe: 12 months

Trial details

NCT IDNCT04542135

SponsorAlison Stopeck

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-22

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