The New England Journal of Medicine reports the results, at the first planned interim analysis (median follow-up of one year), only of treatment with trastuzumab for one year or observation. 

The Herceptin Adjuvant (HERA) (Breast International Group [BIG] 01-01) Trial is an international, intergroup, open-label, phase 3 randomized trial involving women with HER2-positive (overexpressing or amplified) early-stage invasive breast cancer who completed locoregional therapy (surgery with or without radiotherapy) and a minimum of four courses of chemotherapy.

The study was conducted under the auspices of the Breast International Group (BIG), and the pharmaceutical sponsor, Roche – all of which were represented in the steering committee of the HERA trial. The study was designed by members of the steering committee. The database resided in a system of the sponsor, and access was restricted to data managers of the Breast European Adjuvant Study Team data center and statisticians of Frontier Science (Scotland). The sponsor had no access to the database or the interim analyses. 

Title of Publication

Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer


Martine J. Piccart-Gebhart, Marion Procter, Brian Leyland-Jones, Aron Goldhirsch, Michael Untch, Ian Smith, Luca Gianni, Jose Baselga, Richard Bell, Christian Jackisch, David Cameron, Mitch Dowsett, Carlos H. Barrios, Günther Steger, Chiun-Shen Huang, Michael Andersson, Moshe Inbar, Mikhail Lichinitser, István Láng, Ulrike Nitz, Hiroji Iwata, Christoph Thomssen, Caroline Lohrisch, Thomas M. Suter, Josef Rüschoff, Tamás Sütő, Victoria Greatorex, Carol Ward, Carolyn Straehle, Eleanor McFadden, Stella Dolci, and Richard D. Gelber, for the Herceptin Adjuvant (HERA) Trial Study Team.


The New England Journal of Medicine | Volume 353 | Pages 1659-1672 | 2005