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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01761877.
To accomplish our study aims, we will conduct a phase II, single are trial of sulindac in
postmenopausal women with early stage ER+ breast cancer who are receiving an aromatase
inhibitor as adjuvant hormonal therapy. Approximately 75 breast cancer patients, stable
on AI therapy (minimum of 3 months) for the treatment of their breast cancer will receive
sulindac 150 mg bid for 12 months. Breast imaging will be conducted at baseline, 6 and 12
months.
The primary endpoint of the study will be change in the appearance of the contralateral,
uninvolved breast as measured by quantitative Fat Water Ratio (FWR-MRI) mapping at 12
months in response to sulindac therapy. As changes in breast density in the
contralateral, uninvolved breast will be the primary endpoint of the study, patients with
bilateral breast cancer or those patients undergoing bilateral mastectomies or
reconstruction surgery will be ineligible. Secondary endpoints of the trial include 12
month change in general pain and joint specific stiffness and pain as assessed by the
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). A number of
exploratory endpoints are planned and include comparison of MRI measures of the breast,
tissue biomarkers, and pain at 6 months as early indicators of 12 month responses. For
the tissue biomarkers, core needle biopsies will be obtained in a subset of women who
consent to the procedure from the uninvolved contralateral breast at baseline and at 6
months. Tissue studies will include characterization of tissue histology (graded by
cellularity and stromal elements) and molecular measures of proliferation and apoptosis.
Lead OrganizationStony Brook University Medical Center