It has been found that the chemical changes that take place in a patient's body during the
development of inflammation may provide an environment which stimulates cancer cells. One
step in the development of inflammation is the production of certain chemical substances
which are important in the formation and spread of tumours. These are called prostaglandins.
Cyclo-oxygenase II (COX-2) is an enzyme (a substance that speeds up chemical changes in the
body) involved in the production of these prostaglandins and although it is not usually
present in most tissues it is made at the sites of inflammation. Celecoxib is a selective
Non-Steroidal Anti Inflammatory Drug (NSAID) which works by blocking the action of the COX-2
enzyme, leading to a decrease in the production of prostaglandins and a reduction in
inflammation.
The purpose of this study is therefore to find out if celecoxib can be used after breast
cancer treatment (chemotherapy and/ or radiotherapy) to reduce inflammation and thus reduce
the ability of new tumours to grow and survive.
2590 women with primary breast cancer will be recruited in this study from several locations
in the United Kingdom and Germany. Eligible patients will be randomly allocated a treatment
group, which can be celecoxib or placebo. Both treatments are taken orally (celecoxib 400mg
daily, placebo 2 tablets daily) for a total of 2 years. In addition, hormone receptor
positive patients will receive endocrine treatment as per local practice. Patients will
prematurely discontinue treatment with celecoxib/placebo if disease progression is confirmed
or if patients experience unacceptable toxicity.
Patients will be seen every 6 months for the first 3 years and then off treatment follow-up
is carried out annually. Participating patients will also be given the option to take part in
the pathology sub-study by donating a sample of the tumour tissue collected at the time of
the primary surgery.