NSAID Effects on Clinical and Imaging Breast Biomarkers
Condition: Inflammation; Cancer; Pain; Hypertension
MeSH terms: Inflammation
Intervention: Sulindac
Intervention MeSH terms: Sulindac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: Female
Maximum age: 75 Years
Healthy volunteers: No
Keywords: breast cancer, breast density, chemoprevention

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.