AB01

A randomised trial of epirubicin and cyclosphamide versus epirubicin and paclitaxel in the treatment of women with metastatic breast cancer

Can a new combination of drugs help to treat people with breast cancer that has spread?

What was this study about?

In the early 1990s doctors usually treated women with breast cancer that had spread to other parts of their body with two chemotherapy drugs – epirubicin and cyclosphamide. But researchers had found that another chemotherapy drug called paclitaxel might be more effective. The AB01 trial aimed to test whether a new chemotherapy treatment of epirubicin and paclitaxel would be more effective than the usual treatment at that time – epirubicin and cyclosphamide.

What difference did this study make?

This trial found that the new chemotherapy treatment was no more effective than the usual chemotherapy treatment.

NICE used the results of this study to recommend that paclitaxel should not be used to treat women with breast cancer that had spread to other parts of their body.

Type of study

Randomised trial

Contact details

mrcctu.ctuenquiries@ucl.ac.uk

Who funded the study?

The Medical Research Council, with contributions from the pharmaceutical companies Bristol Myers-Squibb, Pharmacia and Upjohn.

When did it take place?

This trial began recruiting patients in 1996 and closed to recruitment in 1999. The results were published in 2005.

Who was included?

705 patients with breast cancer that had spread to other parts of their body. They came from 62 different hospitals.