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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04542135
• Other study ID #: STOP-BC Trial
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2020
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Stony Brook University
• Contact: Pushpa Talanki
• Phone: 631-638-0815
• Email: pushpa.talanki[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 28, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Sulindac Pill
Randomized participants will receive either 150 mg oral sulindac twice daily.
• Placebo
placebo pills twice daily

Locations

Country	Name	City	State
United States	Cedars Sinai - Cancer	Los Angeles	California
United States	Stony Brook University Cancer Center	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Alison Stopeck	Cedars-Sinai Medical Center, Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent breast density by MRI between treatment arms		12 months
Secondary	Change in percent breast density by MRI between treatment arms		6 months
Secondary	Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy		12 months
Secondary	Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors		12 months