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Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Breast Cancer Clinical Trial

Official title:
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Clinical Trial Summary

Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib.

In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01695226
Study type Interventional
Source Maastricht University Medical Center
Contact
Status Completed
Phase Phase 2
Start date February 2004
View Details
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