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

Phase 2

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Placebo; Drug: Sulindac Pill

• Registration Number: NCT04542135
• Lead Sponsor: Alison Stopeck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2020-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-29

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo pill
Sulindac	Sulindac Pill	sulindac 150 mg

Primary Outcome Measures

Name	Time	Method
Change in percent breast density by MRI between treatment arms	12 months

Secondary Outcome Measures

Name	Time	Method
Change in percent breast density by MRI between treatment arms	6 months
Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy	12 months
Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors	12 months

Trial Locations

Locations (2)

Cedars Sinai - Cancer; 🇺🇸 Los Angeles, California, United States

Stony Brook University Cancer Center; 🇺🇸 Stony Brook, New York, United States