Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Maastricht University Medical Center Pierre Hupperets