ABSTRACT
In this trial, 220 women with metastatic breast cancer that had progressed after one or two chemotherapy regimens and whose tumours overexpressed the HER2/neu (c-erbB-2) oncogene were treated with trastuzumab (Herceptin), with an objective response rate of 15% in the intentto-treat population (95% confidence interval 11-21%). The median duration of response was 9.1 months and the median duration of survival 13 months. Side-effects included infusion-associated fever or chills, occurring usually only during the first infusion and of mild to moderate severity. Cardiac dysfunction occurred in 4.7% of patients.
