Sulindac for Reducing Breast Cancer Risk

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Sulindac for reducing breast cancer risk?

Research shows that Sulindac, a type of nonsteroidal anti-inflammatory drug (NSAID), can reduce breast density, which is a risk factor for breast cancer. Additionally, NSAIDs like Sulindac have been associated with improved outcomes in breast cancer patients. ^{1 2 3 4 5}

Is sulindac generally safe for humans?

Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that has been used in humans for conditions like familial adenomatous polyposis and has shown effectiveness in reducing tumors in animal studies. 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 medication, it may have side effects and should be used under medical supervision. ^{2 4 5 6 7}

How does the drug sulindac reduce breast cancer risk?

Sulindac is unique because it is a non-steroidal anti-inflammatory drug (NSAID) that reduces breast density, a risk factor for breast cancer, and its sulfone metabolite has cancer-preventive properties without affecting prostaglandin synthesis, which is different from other treatments that typically target inflammation pathways. ^{2 4 7 8 9}

Research Team

Patricia A Thompson-Carino, PhD

Principal Investigator

Stony Brook University

Alison S Stopeck, MD

Principal Investigator

Stony Brook University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of sulindac plus 5-fluorouracil and levamisole: potential adjuvant therapy for colon carcinoma. [2013]

2. England pubmed.ncbi.nlm.nih.gov

The sulfide metabolite of sulindac prevents tumors and restores enterocyte apoptosis in a murine model of familial adenomatous polyposis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Low-dose Aspirin, Nonsteroidal Anti-inflammatory Drugs, Selective COX-2 Inhibitors and Breast Cancer Recurrence. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sulindac, a Nonselective NSAID, Reduces Breast Density in Postmenopausal Women with Breast Cancer Treated with Aromatase Inhibitors. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Randomized phase II trial of sulindac for lung cancer chemoprevention. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A protective effect of sulindac against chemically-induced primary colonic tumours in mice. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Sulindac increases the expression of APC mRNA in malignant colonic epithelial cells: an in vitro study. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Sulindac and polyp regression. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Sulfone metabolite of sulindac inhibits mammary carcinogenesis. [2013]