Breast Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT04542135

Recruitment Status:

Recruiting

Sponsor:

Stony Brook University

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There are 2 Locations for this study

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Cedars Sinai - Cancer
Los Angeles California, 90048, United States More Info
Jane Ngo
Contact
[email protected]
Patricia Thompson, PhD
Contact
[email protected]
Farin Amersi, MD
Principal Investigator
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States More Info
Pushpa Talanki
Contact
631-638-0815
[email protected]
Caterina Vacchi-Suzzi, PhD
Contact
631-216-2993
[email protected]
Alison Stopeck, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT04542135

Recruitment Status:

Recruiting

Sponsor:


Stony Brook University

How clear is this clinincal trial information?

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