1.1 Trastuzumab in combination with paclitaxel (combination trastuzumab is currently only licensed for use with paclitaxel) is recommended as an option for people with tumours expressing human epidermal growth factor receptor 2 (HER2) scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate.
1.2 Trastuzumab monotherapy is recommended as an option for people with tumours expressing HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for metastatic breast cancer. Prior chemotherapy must have included at least an anthracycline and a taxane where these treatments are appropriate. It should also have included hormonal therapy in suitable oestrogen receptor positive patients.
1.3 HER2 levels should be scored using validated immunohistochemical techniques and in accordance with published guidelines. Laboratories offering tissue sample immunocytochemical or other predictive tests for therapy response should use validated standardised assay methods and participate in and demonstrate satisfactory performance in a recognised external quality assurance scheme.