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

NCT04542135 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

DRUG

Sulindac Pill

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

DRUG

Placebo

placebo pills twice daily

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Alison Stopeck

    lead OTHER

Principal Investigators

  • Alison S Stopeck, MD · Stony Brook University

  • Patricia A Thompson-Carino, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2025-04-22
Completion
2025-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04542135 on ClinicalTrials.gov