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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

Trial details

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

ISRCTN: 48254013

Sponsor: Imperial College London

Source of funding: Pfizer

Further information

Further information on the REACT trial may be found on the following sites:

View REACT on the National Institute for Health Research website: NIHR - Be Part Of Research

Patient friendly information on REACT at CancerHelp UK

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.