Spots Global Cancer Trial Database for Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
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Trial Identification
Brief Title: Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Official Title: Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer
Study ID: NCT01695226
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University Hospital Maastricht, Maastricht, Limburg, Netherlands
Contact Details
Name: Pierre SJ Hupperets, MD; PhD
Affiliation: Maastricht University Medical Centre
Role: PRINCIPAL_INVESTIGATOR
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