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

NCT04542135 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: STOP-BC Trial
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Breast Density

Outcome Measures

Primary Outcomes (1)

• Change in Percent Breast Density by MRI Between Treatment Arms

  The primary objective of this study is to determine if sulindac at a dose of 150 mg BID for 12 months reduces breast density in postmenopausal women at elevated risk of breast cancer when compared to a placebo control. The dependent variable is the relative change in percent breast density. Percent breast density is the estimated percentage of breast volume that appears dense versus fatty on the MRI, and relative change is calculated as the difference between the follow-up and baseline values divided by the baseline value.

  12 months

Secondary Outcomes (2)

• Change in Percent Breast Density by MRI Between Treatment Arms

  6 months

• Changes in Percent Breast Density by MRI Within and Between Treatment Arms, Stratified by Use of Aromatase Inhibitors

  12 months

Study Arms (2)

Sulindac

ACTIVE COMPARATOR

sulindac 150 mg

Drug: Sulindac Pill

Placebo

PLACEBO COMPARATOR

placebo pill

Drug: Placebo

Interventions

Sulindac Pill DRUG

Randomized participants will receive either 150 mg oral sulindac twice daily.

Sulindac

Placebo DRUG

placebo pills twice daily

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alison Stopeck: lead
• Medical University of South Carolina: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (2)

Cedars Sinai - Cancer

Los Angeles, California, 90048, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sulindac

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Patricia Thompson-Carino
• Organization: University of Arizona

pcarino@arizona.edu

520-904-0270

Study Officials

• Alison S Stopeck, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

• Patricia A Thompson-Carino, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: November 20, 2020
• Primary Completion: April 22, 2025
• Study Completion: May 19, 2025
• Last Updated: July 17, 2026
• Results First Posted: July 17, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)