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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04542135

Run by

Alison Stopeck

People needed

61

Starts

2020-11-20

Expected to finish

2025-05-19

Last updated by the study team

2026-07-17

Who can join

Age: 35 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai - Cancer — Los Angeles, California, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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