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Could a common painkiller reduce breast cancer risk?

NCT ID NCT04542135

Prevention Sponsor: Alison Stopeck Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial investigates whether sulindac, an NSAID, can reduce breast density in postmenopausal women at elevated risk for breast cancer. High breast density is a known risk factor for the disease. Participants take sulindac or a placebo daily for 12 months, and changes in breast density are measured by MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sulindac, a nonsteroidal anti-inflammatory drug (NSAID)
What this could lead to
If it works, this could point toward a way to lower breast cancer risk by reducing breast density.
What could go wrong
This is a small, early-phase trial, so results may not be conclusive. Sulindac can cause gastrointestinal side effects and other NSAID-related risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

61 people

The number who actually took part.

Started

Nov 2020

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm breast cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Cedars Sinai - Cancer

    Los Angeles, California, 90048, United States

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794, United States

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