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Smith, Procter, Gelber, et al. (2007) showed that 1 year of treatment with Trastuzumab (T) after adjuvant therapy in HER2‐positive patients with breast cancer was superior to Observation (O) alone. They reported a hazard ratio, HR = 0.66 (95% CI 0.47 to 0.91, p‐value = 0.0115) for overall survival in favour of adjuvant treatment. This comparison was from two arms of a three‐arm large multicentre international randomised trial comprising 1698 patients randomised to O, 1703 to T for 1 year (T1) and 1701 to T for 2 years (T2): a total of 5102 patients.

Key features include the following:

 Design: Randomised, multicentre, observation versus active treatment,

 Size: Part of a large trial of 5102 women with HER2‐positive breast cancer,

 Endpoint: Overall survival,

 Analysis: Comparison in 3404 women from the O and T1 groups using survival curves,

 Conclusion: Treatment with T1 after adjuvant chemotherapy has a significant overall survival benefit.