A clinical trial is testing a new combination of chemotherapy to treat breast cancer that has spread to other parts of the body. Women from all over the country who have breast secondaries are being invited to enter.

The purpose of this study is to see whether the addition of a new drug, paclitaxel (Taxol) together with epirubicin (one of the most effective drugs to treat breast cancer) is more or less effective than the standard drug combination of epirubicin and cyclophosphamide.

What is the evidence so far?

One of the standard treatments for metastatic breast cancer in this country is a combination of two drugs, an anthracycline (either epirubicin or doxorubicin) and cyclophosphamide.

Paclitaxel seems to work well. Derived from the yew tree, it is licensed in the UK as first line treatment of metastatic breast cancer where the standard anthracycline treatment has been unsuccessful or is not suitable.

Patients who agree to take part in the trial (called AB01) will receive either the standard treatment or the new combination. Both combinations consist of a maximum of six courses of chemotherapy, with breaks of at least three weeks between courses. A number of tests will also be carried out to monitor the safety of the treatments. These are normal for patients receiving chemotherapy.

It is important to assess the effect of these treatments not only on the disease, but also on the patient. Patients will be asked to fill out two questionnaires each time they visit the clinic for treatment and at some follow-up visits. One is designed to find out about the effect of the treatment on their general wellbeing and quality of life. The other is about how much help they have needed, as a result of their illness, from their family or health professionals.

More than 200 people have been recruited for the trial – the target is 700.

The results of AB01 will not be known for several years. If the combination of epirubicin and paclitaxel proves to be more effective than current standard treatment it will be a step forward in improving the outcome for many thousands of women with metastatic breast cancer.