TY - JOUR
T1 - Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer
AU - Piccart-Gebhart, Martine J.
AU - Procter, Marion
AU - Leyland-Jones, Brian
AU - Goldhirsch, Aron
AU - Untch, Michael
AU - Smith, Ian
AU - Gianni, Luca
AU - Baselga, Jose
AU - Bell, Richard
AU - Jackisch, Christian
AU - Cameron, David
AU - Dowsett, Mitch
AU - Barrios, Carlos H.
AU - Steger, Günther
AU - Huang, Chiun Shen
AU - Andersson, Michael
AU - Inbar, Moshe
AU - Lichinitser, Mikhail
AU - Láng, István
AU - Nitz, Ulrike
AU - Iwata, Hiroji
AU - Thomssen, Christoph
AU - Lohrisch, Caroline
AU - Suter, Thomas M.
AU - Rüschoff, Josef
AU - Süto, Tamás
AU - Greatorex, Victoria
AU - Ward, Carol
AU - Straehle, Carolyn
AU - McFadden, Eleanor
AU - Dolci, M. Stella
AU - Gelber, Richard D.
PY - 2005/10/20
Y1 - 2005/10/20
N2 - 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
AB - 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
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U2 - 10.1056/NEJMoa052306
DO - 10.1056/NEJMoa052306
M3 - Article
C2 - 16236737
AN - SCOPUS:26844503270
VL - 353
SP - 1659
EP - 1672
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 16
ER -