A trial looking at aromatase and COX-2 inhibitors before surgery for post menopausal early breast cancer (NEO EXCEL)

You can enter this trial if you

• Have early invasive breast cancer
• Have permanently stopped having periods (are postmenopausal)
• Have a breast cancer that has receptors for the hormone oestrogen (is ER positive)
• Have breast cancer that measures at least 2cm across
• Have not had treatment for breast cancer before
• Have satisfactory blood test results
• Are well enough to take part (performance status 0, 1 or 2)

You cannot enter this trial if you

• Have cancer in both breasts (bilateral breast cancer)
• Have cancer that has spread (metastasised) to other parts of your body
• Have already had treatment for invasive breast cancer
• Have had any other cancer except carcinoma in situ of the cervix or basal cell carcinoma that have been removed with surgery (resected)
• Have another disease that would make it unsafe for you to have breast surgery or the trial treatment
• Have another illness that could affect the results of the trial
• Have a condition that could be made worse by celecoxib - you can check this with your doctor
• Need ongoing treatment with regular non steroidal anti inflammatory or COX-2 inhibitor medication, apart from aspirin
• Need ongoing treatment with fluconazole, ketoconazole, lithium or ‘ACE inhibitors’ (please note, you should never stop taking medication without talking to your doctor)
• Are known to be allergic to celecoxib, exemestane, letrozole or a group of medicines called ‘sulphonamides’ - you can check this with your doctor
• Have inflammatory bowel disease
• Are taking medication to thin your blood (anti coagulant therapy)

This is a phase 3 trial, which will recruit 256 people. It is a randomised trial. The people taking part are put into 4 treatment groups by a computer. Neither you nor your doctor will be able to choose a group, or know which group you are in. This is called a ‘double blind’ trial.

Everyone in the trial will take an aromatase inhibitor, with celecoxib or a celecoxib ‘dummy’ tablet (a placebo).

If you are in group 1 you will have the aromatase inhibitor exemestane once a day, and celecoxib twice a day.

If you are in group 2 you will have exemestane once a day and a celecoxib dummy (placebo) tablet twice a day.

If you are in group 3 you will have the aromatase inhibitor letrozole once a day, and celecoxib twice a day.

If you are in group 4 you will have letrozole once a day and a celecoxib dummy (placebo) tablet twice a day.

All of the trial medication will be in tablet form. Everyone in the trial will take their medication every day for 16 weeks. You will then have your breast cancer surgery.

When you start your trial treatment, the team will give you a small card to show you are taking part in a trial, and contact details in case of emergency.  You should carry this card with you all the time.

Before you start the trial you will see the doctor and have some tests. These tests include

• Physical examination
• Breast ultrasound scan
• Heart assessment (to check that you are fit enough for the trial medication)
• Blood tests

When you start the trial, and 2 weeks later you will see the doctor and have some blood tests. You may also have a sample of your cancer removed to study in the laboratory (biopsy).

You will then see the doctor every month during the trial for a check up.

When you finish your treatment, you will see the doctor again and have some more tests. These tests include

• Physical examination
• Breast ultrasound scan
• Taking a sample of your cancer (biopsy)
• Blood tests

When you finish the trial treatment you will have your surgery within the next 2 weeks. You will then continue to see your regular doctors as you did before you started the trial.

The trial team will continue to collect information about your health after you have finished the trial. You will need to visit the hospital once a year for five years so that they can do this.

The common side effects of letrozole and exemestane include

• Hot flushes and sweats
• Tiredness or fatigue
• Feeling or being sick
• Painful joints
• Headaches

Celecoxib can make indigestion worse, and very rarely cause stomach bleeding.

You can find out more about the side effects of letrozole and exemestane on CancerHelp UK.