The HERceptin Adjuvant (HERA) trial is an adjuvant trial comparing observation vs one year of Herceptin® vs two years of Herceptin® in women with early stage HER2-positive breast cancer. The study was sponsored by Roche. FSS has worked with the Breast International Group (BIG) and the Coordinating Group, BrEAST, on many aspects of trial management for HERA including data quality control and the statistical analysis of the data.

Results from the HERA Trial showed that 1 year of adjuvant trastuzumab after chemotherapy for patients with HER2-positive early breast cancer significantly improves long-term disease-free survival, compared with observation.

Title of Publication

11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial.


David Cameron, Martine J Piccart-Gebhart, Richard D Gelber, Marion Procter, Aron Goldhirsch, Evandro de Azambuja, Gilberto Castro Jr, Michael Untch, Ian Smith, Luca Gianni, Jose Baselga, Nedal Al-Sakaff, Sabine Lauer, Eleanor McFadden, Brian Leyland-Jones, Richard Bell, Mitch Dowsett, and Christian Jackisch for the Herceptin Adjuvant (HERA) Trial Study Team

Publication Reference

The Lancet | Volume 389 | Issue Number 10075 | Pages 1195-1205 | 16 February 2017