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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Phase 3

This trial is to find the best combination of aromatase and COX-2 inhibitors to shrink postmenopausal breast cancer before surgery. This trial is supported by Cancer Research UK.

Doctors usually treat breast cancer with a combination of surgery, hormone therapy, radiation or chemotherapy. Having chemotherapy before surgery (‘neo adjuvant’) means the operation is smaller because the chemotherapy has already shrunk the cancer. But chemotherapy can have unpleasant side effects.

A hormone therapy called an aromatase inhibitor may give the same results as chemotherapy, with fewer side effects. If your breast cancer cells have oestrogen receptors (ER positive), the female hormone oestrogen can encourage breast cancer growth. After the menopause, your ovaries stop making oestrogen. But your adrenal glands Open a glossary item still produce a small amount. Aromatase inhibitors stop the adrenal glands making oestrogen.

Researchers want to add the drug celecoxib to the aromatase inhibitor to see if this improves how well the treatment works. Celecoxib is a COX-2 inhibitor, which stops the cancer producing a survival enzyme Open a glossary item called cyclo oxygenase. The aims of this trial are to find out

  • Which aromatase inhibitor works best to shrink hormone sensitive breast cancer before surgery
  • If aromatase inhibitors work better with or without a COX-2 inhibitor

Who can enter

You can enter this trial if you

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 Open a glossary item 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)

Trial design

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 Open a glossary item).

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.

Hospital visits

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.

Side effects

The common side effects of letrozole and exemestane include

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.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Adele Francis

Supported by

Cancer Research UK
NIHR Clinical Research Network: Cancer
University Hospital Birmingham NHS Foundation Trust
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/06/005.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 594

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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