A phase III multicentre double blind randomised trial of celecoxib versus placebo in primary breast cancer patients.
Disease site: Breast cancer
Treatment modality: Other
Status: In active follow-up
It has long been recognised that there is an association between chronic immune activation and cancer but the mechanisms behind this observation are not fully understood (O’Byrne and Dalgleish, 2001). The inflammatory process may provide an environment for development of malignant disease, with mediators of inflammatory response such as the cyclo-oxygenases (COX) playing an important role and providing a target for therapeutic intervention.
There is evidence to suggest that COX-2 inhibitors could enhance the adjuvant treatment of breast cancer in inhibition of angiogenesis, cell growth, tumour-associated inflammation, invasion and promoting apoptosis.
In the REACT trial patients, in addition to their standard adjuvant therapy, are randomised between two years celecoxib (a COX-2 inhibitor) and placebo in a 2:1 ratio in favour of celecoxib.
The primary aim of the study is to assess the disease free survival (DFS) benefit of two years adjuvant therapy with celecoxib compared with placebo in primary breast cancer patients. The study requires randomisation of 2,590 patients in total.
This is an International Collaborative Cancer Group (ICCG) trial. REACT is coordinated by the ICCG and the German Breast Group in collaboration with the ICR-CTSU and is run under the auspices of the Breast International Group. The study is part of the NIHR portfolio.
Chief Investigator: Professor R. C. Coombes, Imperial College, London
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: Please visit the ICCG webpages for current contact details
Sponsor: Imperial College London
Source of funding: Pfizer
Further information on the REACT trial may be found on the following sites:
Monthly accrual figures are available from the UKCRN Portfolio
Patient friendly information on REACT at CancerHelp UK