A phase III, multicenter, double-blind, randomized trial of celecoxib versus placebo in primary breast cancer patients: Randomized European Celecoxib Trial (REACT).

TPS115 Background: Celecoxib is a selective COX-2 inhibitor licensed for the treatment of chronic arthritis. However, an association between non-steroidal anti-inflammatory drug (NSAID) use and decreased breast cancer risk in women has also been demonstrated (Harris et al, Epidemiology, 1996), believed to be due to inhibition of the COX-2 enzyme. Preclinical data has shown that COX-2 inhibitors can prevent mammary tumour formation (Harris et al, Can Res, 2000), inhibit angiogenesis (Rozic et al, Int J Cancer, 2001) and reverse resistance to apoptosis (Tsujii et al, Cell, 1995). A review of treatment with aromatase inhibitors and COX-2 inhibitors concluded that interactions between aromatase and COX pathways are involved in tumour formation and progression in breast cancer (Falandry et al, Ann Oncol, 2009). REACT is designed to assess the adjuvant benefit of COX-2 inhibition on treatment of primary breast cancer. Methods: This is an academic study coordinated by the ICCG (UK) and GBG (DE), under the auspic...