A trial looking at celecoxib for women with breast cancer (REACT)

Who can enter

You can enter this trial if you are female and you 

• Have breast cancer that has been completely removed with surgery
• Are currently having radiotherapy or finished radiotherapy within the last 6 weeks, OR had your surgery less than 3 months ago, OR finished chemotherapy between 3 weeks and 4 months ago
• Are well enough to take part (performance status 0 or 1)
• Have satisfactory blood test results
• Are willing to use reliable contraception (apart from the pill) when taking part in the trial if there is any chance that you may become pregnant
• Are at least 18 years old

If your breast cancer is NOT hormone sensitive, you must have had chemotherapy before you can take part in this trial

You cannot enter this trial if

• Your breast cancer has not spread to your lymph nodes AND your tumour is 2cm or less AND it is grade 1
• Your doctors think you have a lower than average risk of your breast cancer coming back (your doctor will tell you more about this)
• You have locally advanced or metastatic breast cancer
• You have cancer in both breasts
• Your breast cancer is HER2 positive (score of 3+)
• You have been taking part in another clinical trial, and the doctor in charge of that trial has not given permission for you to take part in this trial
• You have had any other cancer in the past 10 years (apart from non melanoma skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
• You have other medical problems, such as a stomach ulcer, inflammatory bowel disease, heart problems, uncontrolled high blood pressure, insulin dependent diabetes, a stroke, heart attack , or osteoporosis that is causing you symptoms
• You have taken hormone replacement therapy within the last 6 weeks
• You are allergic to celecoxib, non steroid anti inflammatory drugs (NSAIDs), sulphonamides (a type of antibiotic) or salicylates (an ingredient in aspirin)
• You have been taking anti inflammatory drugs for more than 6 weeks, or you plan to take them for more than 6 weeks in the future (you might be able to take part if you take a daily low dose of aspirin)
• You are currently taking steroids, or you have taken them for a long time in the past
• You are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 2,590 women into 2 groups. The people taking part are put into treatment groups by computer. Neither you, nor your doctor, will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial.

If you are in group 1, you will have celecoxib. If you are in group 2, you will have dummy tablets (placebo).

You will take either the placebo or the celecoxib tablets once a day for up to 2 years.

If you have hormone sensitive breast cancer you will also take hormone treatment. This will be prescribed by your consultant.

The researchers would like to look at a sample of your breast cancer that was kept by the doctors when you had your surgery. It will help the researchers learn more about breast cancer.

Hospital visits

You will see the doctors and have some tests before you can take part in the trial. These include

• Heart trace (ECG)
• Blood tests
• Physical examination

You may also need to have another mammogram. Some women may need to have further tests to check that their cancer has not spread. These may include a CT scan, ultrasound scan and bone scan.

You will go to the hospital to see the doctors 

• After 3 months, 6 months and 12 months in the first year, then
• Every 6 months in the 2nd and 3rd year, then
• Once a year for up to 10 years

You will have another heart trace (ECG) and blood test after one year, and when you stop taking the celecoxib or placebo.

Side effects

The most common side effects of celecoxib are

• Stomach pains
• Painful sinuses (sinusitis)
• Rash

There may also be a small increase in risk of heart attack or stroke when taking celecoxib.