Sulindac for Reducing Breast Cancer Risk

No longer recruiting at 1 trial location

Overseen By Caterina Vacchi-Suzzi, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Alison Stopeck

Must not be taking: Aspirin, Anti-inflammatories, SERMs

Disqualifiers: Cardiovascular disorders, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug sulindac can lower breast density in postmenopausal women at higher risk for breast cancer. Reducing breast density might decrease the chance of developing breast cancer. Participants will take either a sulindac pill or a placebo (a pill with no active drug) for 12 months. This trial suits women with dense breasts and a family history or genetic risk of breast cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage research.

Will I have to stop taking my current medications?

The trial requires that you do not take daily aspirin or other daily anti-inflammatory medications. Hormonal therapy with aromatase inhibitors is allowed, but you cannot have used selective estrogen receptor modulators like tamoxifen or raloxifene in the past 12 months.

Is there any evidence suggesting that sulindac is likely to be safe for humans?

Research has shown that sulindac is generally safe to use. Although specific safety details for its use in reducing breast cancer risk are not available, sulindac's common use for other health issues suggests it is mostly safe.

In other studies, participants have taken sulindac long-term without serious problems. Like any medication, it can cause side effects, but they are usually mild. Consulting a healthcare provider before joining a clinical trial is important to understand any potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for reducing breast cancer risk, which often involve hormone therapy or surgery, sulindac is a non-steroidal anti-inflammatory drug (NSAID) traditionally used for pain relief. Researchers are excited about sulindac because it targets inflammation pathways, which might play a role in cancer development. This unique mechanism offers a non-hormonal option that could potentially reduce breast cancer risk with fewer side effects than current methods.

What evidence suggests that sulindac might be an effective treatment for reducing breast cancer risk?

Previous studies have shown that sulindac can reduce breast density, a known risk factor for breast cancer. Research suggests that sulindac may help restore the body's ability to fight cancer. In animal studies, sulindac slowed tumor growth and increased survival in mice with breast cancer. This trial will administer either sulindac or a placebo to participants to evaluate its potential in reducing breast cancer risk in high-risk women. Evidence suggests that sulindac could be a helpful tool in this regard. ^{1 5 6 7 8}

Who Is on the Research Team?

Patricia A Thompson-Carino, PhD

Principal Investigator

University of Arizona

Alison S Stopeck, MD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for postmenopausal women under 70 with dense breasts and a higher risk of breast cancer due to family history, genetic factors, or abnormal tissue findings. Participants must have normal organ function and no prior invasive breast cancer treatments. They cannot be regular smokers, use daily anti-inflammatories or certain hormone therapies recently, nor have conditions like uncontrolled hypertension or insulin-requiring diabetes.

Inclusion Criteria

You have a negative test for hidden blood in your stool.

My organs are functioning normally.

I have one breast without any history of cancer, radiation, or implants.

Exclusion Criteria

Cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses that would preclude MRI.

I do not have serious stomach, bleeding, or heart problems.

You are known to have a bad reaction to anti-inflammatory drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sulindac 150 mg twice a day or placebo for 12 months to assess reduction in breast density

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sulindac Pill

Trial Overview The study tests if taking Sulindac (150 mg twice daily) for a year can reduce breast density in women at high risk of developing breast cancer compared to a placebo. The goal is to see if this treatment could potentially lower the chance of getting breast cancer.

How Is the Trial Designed?

Group I: Sulindac Active Control 1 Intervention

sulindac 150 mg

Group II: Placebo Placebo Group 1 Intervention

placebo pill

Who Is Running the Clinical Trial?

Alison Stopeck

Lead Sponsor

Trials

4

Recruited

220+

Stony Brook University

Lead Sponsor

Trials

225

Recruited

41,700+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Cedars-Sinai Medical Center

Collaborator

Trials

523

Recruited

165,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8793363/

Sulindac, a non-selective NSAID, reduces breast density in ... To evaluate the effect of sulindac, a non-selective anti-inflammatory drug, for activity to reduce breast density (BD), a risk factor for breast cancer.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04542135

Sulindac and Breast Density in Women at Risk ... 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 ...

3. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-025-02134-2

The nonsteroidal anti-inflammatory drug sulindac reverses ... Specifically, sulindac restores markers of antitumor immunity while suppressing tumor growth and metastasis; enforcing a tumoral metabolic ...

4. nature.com nature.com/articles/srep19534

Sulindac, a non-steroidal anti-inflammatory drug, mediates ... Our data showed that sulindac had substantial efficacy as a single agent against 4T1 murine breast cancer and prolonged the survival of tumor-bearing mice.

5. withpower.com withpower.com/trial/phase-3-breast-neoplasms-10-2020-9441c?lat=36.65114&lng=-97.3517

Sulindac for Reducing Breast Cancer Risk Trial Overview The study tests if taking Sulindac (150 mg twice daily) for a year can reduce breast density in women at high risk of developing breast cancer ...

6. withpower.com withpower.com/trial/phase-3-breast-neoplasms-10-2020-9441c

Sulindac for Reducing Breast Cancer Risk While specific safety data for breast cancer risk reduction is not detailed, its use in other conditions suggests it is generally safe, but as with any ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9913705/

Novel Non-Cyclooxygenase Inhibitory Derivative of ... Epidemiological studies have demonstrated that the long-term, high dose use of NSAIDs such as sulindac can lower the risk of breast cancer [ · As ...

8. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1244159/full

Sulindac sulfide as a non-immune suppressive γ-secretase ... Harris et al. reported that long-term regular use of any NSAID reduced the risk of breast cancer by 28% (62). ... breast cancer through reduction of cancer stem ...