作者
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, M Stella Dolci, Richard D Gelber
发表日期
2005/10/20
期刊
New England Journal of Medicine
卷号
353
期号
16
页码范围
1659-1672
出版商
Massachusetts Medical Society
简介
Background
Trastuzumab, a recombinant monoclonal antibody against HER2, has clinical activity in advanced breast cancer that overexpresses HER2. We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy.
Methods
This international, multicenter, randomized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy.
Results
Data were available for 1694 women randomly assigned to two years of treatment with trastuzumab, 1694 women assigned to one year of trastuzumab, and 1693 women assigned to observation. We report here the results only of treatment with trastuzumab for one year or observation. At the first planned …
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MJ Piccart-Gebhart, M Procter, B Leyland-Jones… - New England Journal of Medicine, 2005