A trial to see if zoledronic acid can help chemotherapy work better before surgery for breast cancer (ANZAC)

Please note this trial is no longer recruiting patients.

This trial is to see if using zoledronic acid with chemotherapy will help treat breast cancer.

Zoledronic acid (Zometa or Zoledronate) is a bisphosphonate. Doctors use bisphosphonates to reduce pain and damage that may happen when cancer spreads to the bones. We know from laboratory research that zoledronic acid kills breast cancer cells. Researchers in the laboratory have now found that using zoledronic acid and chemotherapy together may kill more cancer cells.

Many of these results are from looking at cancer cells in a laboratory. Now researchers want to see if adding zoledronic acid to chemotherapy increases the number of cancer cells that die as a result of treatment. This is a pilot study. If researchers see encouraging results, they may go on to a larger trial. The aim of this trial is to see whether adding zoledronic acid to breast cancer chemotherapy helps chemotherapy to work better before surgery.

Recruitment

Start 30/07/2007

End 31/07/2009

Phase

Phase 2

Who can enter

You can enter this trial if you

Are a patient being treated in Sheffield
Are a woman with invasive breast cancer
Have breast cancer that is at least 2 centimetres across (stage T2)
Need to have chemotherapy before your surgery
Have had, or will have, a breast tissue sample taken to examine under the microscope (a core biopsy)
Are willing to have another core biopsy before your second cycle of chemotherapy
Have satisfactory blood test results
Are well enough to take part (performance status 0, 1 or 2)
Are willing to use reliable contraception if there is a possibility that you might become pregnant
Are over 18 years old

You cannot enter this trial if you

Have breast cancer that has spread to another part of your body (metastasised), or has come back after treatment (recurred)
Have already had chemotherapy, or radiotherapy to your breast
Have had bisphosphonate treatment in the last year
Are taking tamoxifen or an aromatase inhibitor that will not stop before the trial
Need to take medication to thin your blood (made from warfarin or coumarin)
Are allergic to bisphosphonates
Have had any other cancer in the last 5 years, apart from cancer in your other breast (more than 6 months ago and you did not have chemotherapy) or carcinoma in situ of the cervix or non melanoma skin cancer that has been successfully treated
Have heart problems that may be made worse by the types of chemotherapy used in the trial
Have problems with your mouth or teeth including infection or a bone condition in your jaw called osteonecrosis
Have had in the past 4 weeks, or are due to have, dental or jaw surgery (minor gum surgery doesn’t count)
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit 40 women into one of 2 groups. 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.

Everyone in the trial will have the same standard chemotherapy treatment. If you are in group 1, you will just have chemotherapy. If you are in group 2, you will also have one dose of zoledronic acid through a drip into a vein. This will take about 15 minutes.

Everyone will have a core biopsy on the 5th day of their first cycle of chemotherapy. After your last cycle of chemotherapy, you will have surgery.

Hospital visits

Before you start the trial, you will see the doctor and have a blood test.

During this trial, you will come to the hospital for chemotherapy and surgery, as you would if not in the trial.

If you are in group 2, you will also have to come to the hospital to have zoledronic acid 24 hours after your first chemotherapy treatment.

Everyone in the trial will have to come to hospital for a 2nd core biopsy, on the 5th day of the first chemotherapy cycle. You may also have another biopsy about 3 weeks after your first cycle of chemotherapy.

At various points in the trial, you will also have some blood and urine tests when you come to the hospital for these appointments.

After the trial, you will continue to see your own cancer doctor in the same way as you did before the trial.