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 NitzHiroji Iwata, Christoph Thomssen, Caroline Lohrisch, Thomas M. Suter, Josef Rüschoff, Tamás Süto, Victoria Greatorex, Carol Ward, Carolyn Straehle, Eleanor McFadden, M. Stella Dolci, Richard D. Gelber

Research output: Contribution to journalArticlepeer-review


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 interim analysis (median follow-up of one year), 347 events (recurrence of breast cancer, contralateral breast cancer, second nonbreast malignant disease, or death) were observed: 127 events in the trastuzumab group and 220 in the observation group. The unadjusted hazard ratio for an event in the trastuzumab group, as compared with the observation group, was 0.54 (95 percent confidence interval, 0.43 to 0.67; P

Original languageEnglish
Pages (from-to)1659-1672
Number of pages14
JournalNew England Journal of Medicine
Issue number16
Publication statusPublished - Oct 20 2005

ASJC Scopus subject areas

  • Medicine(all)


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