A trial looking at zoledronic acid to try to stop breast cancer coming back (AZURE)

Who can enter

You can enter this trial if you

• Have had surgery for stage 2 or 3 breast cancer that has spread to your lymph nodes, or
• Are due to have surgery soon for stage 3 breast cancer that is greater than 5 cm, or
• Have stage 3 breast cancer and have had, or are due to have, radiotherapy if you cannot have surgery to remove it
• Are due to have chemotherapy and/or hormone therapy
• Are well enough to have treatment
• Have satisfactory blood test results
• Are at least 18 years old
• Are willing to use contraception if there is any chance you could become pregnant

You cannot enter this trial if you

• Have stage 1 or stage 4 breast cancer
• Have had breast cancer before
• Have had treatment before surgery (neo adjuvant treatment), unless it was less than 30 days of hormone therapy
• Have had treatment with bisphosphonates within the last year
• Have had any other cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
• Have problems with your bones such as osteoporosis
• Have had an operation on your jaw in the last 4 weeks (not including a filling), or have an infection in your jaw bone
• Are pregnant or breastfeeding
• Have had an unlicensed drug as part of a clinical trial in the last month

Trial design

This trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. There are 2 groups. If you are in group 1 you will have standard treatment after your operation. This may include radiotherapy, chemotherapy and hormone therapy. The exact treatment you have will depend on the type and stage of your breast cancer. You will not have zoledronic acid.

If you are in group 2 you will have standard treatment and zoledronic acid. You will be given zoledronic acid as a drip into a vein. This will take about 15 minutes. You will have this

• Every 3 to 4 weeks for 4 to 6 months (6 doses)
• Every 3 months for 2 years (8 doses)
• Every 6 months for 2 and 1/2 years (5 doses)

In total you will have zoledronic acid 19 times over about 5 years. If your breast cancer spreads to another part of your body during this time, you may not have any further doses of zoledronic acid. Your doctor will tell you whether or not you can carry on taking zoledronic acid.

All the people taking part in this trial will take calcium and vitamin D tablets for at least the first 6 months. And maybe for the full 5 years.

As part of this trial your doctors will ask you if they can keep a sample of your cancer and a blood sample. The researchers will store the samples and use them in the future to help doctors understand more about breast cancer. You do not have to agree to this part of the trial.

Hospital visits

If you are in group 2 you will go to the hospital 19 times over about 5 years to have zoledronic acid. If you are having chemotherapy, the zoledronic acid can probably be given on the same day. You will see the doctor at the hospital once a year for 5 years after that.

If you are in group 1 you will need to go to the hospital to see the doctors 19 times in the first 5 years. And once a year for 5 years after that. This is the same number of times as the women in group 2. Doing this makes it is easier for the doctors to compare the results.

The doctors will do some blood tests and ask you how you have been feeling. You will have a physical examination regularly while you are taking part in the trial. You will not have any other extra test as a result of taking part in this trial. But you will have some tests and scans as part of your standard follow up.

Side effects

All drugs have some side effects. The most common side effects of zoledronic acid are

• Flu like symptoms
• Tiredness
• Feeling or being sick
• Headaches
• Taste changes

Very rarely, bisphosphonates such as zoledronic acid can cause damage to your jaw bone. This is called 'osteonecrosis'. There is more information about the side effects of zoledronic acid on CancerHelp UK.