Last updated on December 2018

NSAID Effects on Clinical and Imaging Breast Biomarkers

Brief description of study

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.

Detailed Study Description

To accomplish our study aims, we will conduct a non-randomized phase II trial of AI alone as anastrozole in combination with sulindac in postmenopausal women with early stage ER+ breast cancer who are receiving an anastrozole as their adjuvant hormonal therapy. Recruitment will be limited to women on anastrozole to reduce heterogeneity introduced by other AIs. Anastrozole is selected as it is the only AI available in generic form and currently comprises almost 100% of our patient population. Approximately 100 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, 3, 9 and 15 months. A one-month run-in period followed by a 3-month observation, no agent period will be used to identify subjects likely not to adhere to the study regimen and to determine the extent of variability in breast density over time.

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 either control (anastrozole alone) or experimental (anastrozole + 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 between arms in diffusion weighted MRI (median ADC value) and general pain and joint specific stiffness and pain as assessed by the BPI-SF. 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. This is anticipated to be ~75% at baseline (n=100) (provides tissue sample for cross sectional comparative analyses with MRI features at baseline) and ~25% at 6 month follow-up visit (n=37) (provides tissue to conduct analyses of biomarker response to intervention). Tissue studies will include characterization of tissue histology (graded by cellularity and stromal elements) and molecular measures of proliferation and apoptosis.

Clinical Study Identifier: NCT01761877

Contact Investigators or Research Sites near you

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Pavani Chalasani, MD

University of Arizona Cancer Center
Tucson, AZ United States

Alison Stopeck, MD

Stony Brook University Cancer Center
Stony Brook, NY United States

Recruitment Status: Closed

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