Sulindac and Breast Density in Women at Risk of Developing Breast Cancer
NCT ID: NCT04542135
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2020-11-20
2025-05-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
NCT00418236
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
NCT00099437
Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients
NCT03847311
Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors
NCT01196936
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
NCT00754325
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sulindac
sulindac 150 mg
Sulindac Pill
Randomized participants will receive either 150 mg oral sulindac twice daily.
Placebo
placebo pill
Placebo
placebo pills twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sulindac Pill
Randomized participants will receive either 150 mg oral sulindac twice daily.
Placebo
placebo pills twice daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
35 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of South Carolina
OTHER
Cedars-Sinai Medical Center
OTHER
Alison Stopeck
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alison Stopeck
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alison S Stopeck, MD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Patricia A Thompson-Carino, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars Sinai - Cancer
Los Angeles, California, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STOP-BC Trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.