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Nonsteroidal Anti-inflammatory Drug

Sulindac for Reducing Breast Cancer Risk

Phase 2
Recruiting
Led By Patricia A Thompson-Carino, PhD
Research Sponsored by Alison Stopeck
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal organ function
Must have at least one healthy normal appearing breast (no prior diagnosis of invasive cancer, radiation or prosthetics). Prior biopsies are acceptable.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test whether sulindac can help reduce breast density in postmenopausal women who are at increased risk of breast cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Sulindac may cause side effects such as digestive issues (like stomach pain), potential bleeding problems, liver changes detected by blood tests, and possibly an increased risk of heart-related events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are functioning normally.
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I have one breast without any history of cancer, radiation, or implants.
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I have gone through menopause.
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My breasts are classified as dense.
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I am at high risk for breast cancer due to abnormal tests, family history, or genetics.
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I am on hormonal therapy with aromatase inhibitors.
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I am 70 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in collagen fiber alignment by second harmonic generation microscopy in breast tissue by biopsy
Change in percent breast density by MRI between treatment arms
Changes in in percent breast density by MRI within and between treatment arms, stratified by use of aromatase inhibitors

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: SulindacActive Control1 Intervention
sulindac 150 mg
Group II: PlaceboPlacebo Group1 Intervention
placebo pill

Find a Location

Who is running the clinical trial?

Alison StopeckLead Sponsor
3 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Breast Cancer
60 Patients Enrolled for Breast Cancer
Medical University of South CarolinaOTHER
930 Previous Clinical Trials
7,393,661 Total Patients Enrolled
10 Trials studying Breast Cancer
499 Patients Enrolled for Breast Cancer
Cedars-Sinai Medical CenterOTHER
497 Previous Clinical Trials
164,409 Total Patients Enrolled
16 Trials studying Breast Cancer
1,974 Patients Enrolled for Breast Cancer

Media Library

Sulindac Pill (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04542135 — Phase 2
Breast Cancer Research Study Groups: Sulindac, Placebo
Breast Cancer Clinical Trial 2023: Sulindac Pill Highlights & Side Effects. Trial Name: NCT04542135 — Phase 2
Sulindac Pill (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542135 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial the inaugural attempt at a study of its kind?

"Currently, 4 experiments surrounding Sulindac are being conducted across 623 cities in 2 different countries. In 2013, Cancer Prevention Pharmaceuticals, Inc. commenced a Phase 3 trial with 1340 participants; since then 18334 additional trials have been finalized."

Answered by AI

Could you elucidate the potential risks of taking Sulindac?

"Taking into consideration the Phase 2 nature of this trial, our team at Power estimated Sulindac's safety to be a score of 2 due to limited data on its efficacy."

Answered by AI

What is the maximum number of participants for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial continues its search for 150 participants at two different locations since it was first posted on November 20th 2020 and edited more recently on February 23rd 2022."

Answered by AI

In what conditions is Sulindac typically prescribed?

"Generally, sulindac is utilized to manage acute subacromial bursitis. Additionally, the drug has been demonstrated to be effective for cases of osteoarthritis (OA), acute supraspinatus tendinitis, and gouty arthritis."

Answered by AI

Is enrollment for this research project still open?

"According to clinicaltrials.gov, this research project continues to search for additional participants since its first posting on November 20th 2020 and most recent update on February 23rd 2022."

Answered by AI

Could you elucidate the past investigations that have utilized Sulindac?

"In 2013, Lake Norman Hematology Oncology Specialists-Mooresville first began examining sulindac. Nowadays, there are 18334 completed trials and 4 studies in the process of recruitment; many of these involve Stony Brook University's New york campus."

Answered by AI
~30 spots leftby Jan 2025