Trastuzumab 150mg vial (Herceptin)

Following a full submission.

Trastuzumab (Herceptin®) is accepted for restricted use within NHSScotland for the treatment of patients with HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).

In the pivotal trial, the addition of one year of 3-weekly trastuzumab after adjuvant chemotherapy significantly increased disease-free survival compared with that in the observation group. The trial excluded patients with a range of cardiovascular conditions and trastuzumab treatment for early breast cancer is not recommended in such patients. In patients treated with trastuzumab for early breast cancer, monitoring of cardiac function is required before treatment, every three months during treatment and for up to two years after treatment has stopped.

Trastuzumab in this indication is restricted to use by breast cancer specialists.