A Phase 2 interventional study of Celecoxib in Breast Carcinoma, sponsored by University of Wisconsin, Madison. Withdrawn. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Basic science
The overall purpose of this study is to assess whether celecoxib can reduce the change in collagen alignment and inflammatory response in the tumor tissue of primary breast cancer patients with invasive breast carcinoma after 2 weeks of oral intake.
Advances in early detection techniques and improvement in systemic treatment of early stage breast cancer have led to a small decline in overall breast cancer mortality in the last 20 years. New advances will require understanding of breast cancer biology at the molecular level. Inhibition of COX-2 and its analysis of effect in breast cancer tumor microenvironment provide one such fruitful therapeutic target. Tumor microenvironment is poorly understood in breast cancer research. Despite new drugs being developed to treat breast cancer and tested in clinical trials, it is rarely possible to assess how the drug is affecting the breast cancer cells at a molecular level. The use of collagen properties such as alignment and deposition will allow giving a faster diagnosis of breast cancer status and seeing how celecoxib with respect to collagen can change the tumor microenvironment in human tissue. This window trial provides a way to look at cancer and stromal cells before and after celecoxib intake to see if the drug is actively working. If we can do this before and after a patient has surgery, and see how the tumor microenvironment responds, then the physician could pick a better suited adjuvant treatment for this patient after surgical intervention that would improve their overall survival rate.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
Browse Carcinoma studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
The participants will be scheduled for the two quantitative breast MRI exams. Following the first MRI exam, participants will start taking celecoxib 200mg twice a day with food. Subjects will take a minimum of 26 doses and no more than 32 doses of celecoxib during the study. Participants will intake 200mg of celecoxib two times a day (400mg/day total) for 2 weeks after biopsy. Histologic tissue samples will be obtained for evaluation at time of biopsy of the tumor and at time of surgery removal of the tumor.
Drug: Celecoxib
Celecoxib is the only COX-2 inhibitor currently approved by the FDA to be used in the United States. Recently, it has been shown that celecoxib prevents sporadic colorectal adenomas and there are more clinical trials evaluating the use of celecoxib in combination with chemotherapy regimens in breast cancer settings. Celebrex® oral capsules that will be used in this study contain 200 mg of celecoxib, in combination with inactive ingredients that include the following components: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
Also known as: Celebrex
Changes in collagen
To determine change of collagen structure and proliferation in response to celecoxib intake in the tumor microenvironment.
Time frame: Up to 6 weeks
Change in correlation of collagen alignment and COX-2 expression
To evaluate correlation among collagen alignment and COX-2 expression before and after celecoxib intake.
Time frame: Up to 6 weeks
Changes in Syndecan-1
To analyze Syndecan-1 expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in CD68
To analyze CD68 expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in CD163
To analyze CD163 expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in neutrophil elastase
To analyze neutrophil elastase expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in vimentin
To analyze vimentin expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in α-SMA
To analyze α-SMA expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in Ki67
To analyze Ki67 expression levels as stromal response biomarkers.
Time frame: Up to 6 weeks
Changes in tissue cytokines in dense breast tissue
To discover tissue cytokines present in dense breast tissue that are altered in response to celecoxib.
Time frame: Up to 6 weeks
Number of subjects with adverse events associated with celecoxib
To evaluate any adverse events associated with the 2-week intake of 200mg celecoxib twice a day.
Time frame: Up to 6 weeks
Changes in collagen due to relationship of amount/percentage of fibroglandular tissue
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 MRI.
Time frame: Up to 6 weeks
No study locations are listed for this record.
This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison