NSAID Effects on Clinical and Imaging Breast Biomarkers

Completed · Phase 2

Conditions studied: Inflammation, Cancer, Pain, Hypertension

In brief

This study has two purposes. One is to determine if daily sulindac decreases breast density; a risk factor for breast cancer development. The second is to determine whether sulindac reduces pain and stiffness associated with regular use of aromatase inhibitors given for the treatment of breast cancer.

Key facts

Study ID

NCT01761877

Run by

Stony Brook University

People needed

114

Starts

2012-12-01

Expected to finish

2019-03-11

Last updated by the study team

2023-02-10

Who can join

Age: any, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility criteria will include: Postmenopausal women with of first incidence of early stage (stages 0 - III) hormone receptor positive breast cancer stabilized on anastrozole therapy for at least 3 months
• Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of 12 months
• Patients must have an unaffected, non-irradiated contralateral breast with a baseline breast density score of > 25% as measured by standard digital mammography (BIRADs score > 2) or magnetic resonance imaging (MRI) performed within 12 months of randomization to the study
• A willingness to follow the study protocol, as indicated by provision of informed consent to participate
• A willingness to avoid taking NSAIDs outside of the trial (rare NSAID use for musculoskeletal symptoms excepted)
• Normal renal function as determined by a serum creatinine < upper limit of normal
• No known contraindication to NSAID use
• Normotensive or controlled blood pressure (< 140/90) on a single anti-hypertensive medication

You may not qualify if…

• Current or anticipated need for daily aspirin or NSAID use including aspirin for cardiovascular protection
• Known intolerance to NSAIDs
• Age > 75 years
• History of cardiovascular disease including prior myocardial infarction, angina, stroke, or transient ischemic attack (TIA)
• Diabetes requiring drug therapy
• Current smoker
• History of Uncontrolled hypertension
• Blood pressure > 140/90 at baseline by home monitoring
• History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
• History of a bleeding diathesis or current anticoagulant therapy
• Daily therapy with H2 blockers or protein pump inhibitors
• History of claustrophobia
• Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• Stony Brook University Cancer Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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