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Completed

NCT Number: NCT04542135

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

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.

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Key information

Conditions

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

Age range

35 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cedars Sinai - Cancer, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Sulindac Pill

Drug

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

Placebo

Drug

placebo pills twice daily

Primary outcomes

  1. Change in Percent Breast Density by MRI Between Treatment Arms

    Time frame: 12 months

    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.

Secondary outcomes

  1. Change in Percent Breast Density by MRI Between Treatment Arms

    Time frame: 6 months

    The secondary objective of this study is to determine if sulindac at a dose of 150 mg BID for 6 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.

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

    Time frame: 12 months

    The secondary objective 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, with analyses stratified by aromatase inhibitor (AI) use. Results are reported separately for participants on AI therapy and those not on AI therapy.

Sponsors and collaborators

Lead sponsor

Alison Stopeck

Other

Collaborators

  • Cedars-Sinai Medical Center
  • Medical University of South Carolina

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2020
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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