This phase II trials studies how well celecoxib works in reducing collagen from multiplying or increasing in patients with breast cancer undergoing surgery. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03185871.
PRIMARY OBJECTIVES:
I. To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.
SECONDARY OBJECTIVES:
I. To evaluate correlation among collagen alignment and COX-2 expression before and after celecoxib intake.
II. To analyze syndecan-1, CD68, CD163, neutrophil elastase, vimentin, alpha-SMA and Ki67 expression levels as stromal response biomarkers.
III. To discover tissue cytokines present in dense breast tissue that are altered in response to celecoxib.
IV. To evaluate any adverse events associated with the 2-week intake of 200 mg celecoxib twice a day.
V. To determine if changes in collagen structure and proliferation in response to celecoxib differ by the amount and/or percentage of fibroglandular tissue, measured quantitatively using magnetic resonance imaging (MRI).
OUTLINE:
Patients receive celecoxib orally (PO) twice daily (BID) on days 1-13 in the absence of disease progression or unacceptable toxicity.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorMark Edward Burkard
