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, I. 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

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Abstract

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
Volume353
Issue number16
DOIs
Publication statusPublished - Oct 20 2005

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Adjuvant Chemotherapy
Breast Neoplasms
Observation
Trastuzumab
Multicenter Studies
Therapeutics
Monoclonal Antibodies
Confidence Intervals
Safety
Recurrence
Drug Therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Piccart-Gebhart, M. J., Procter, M., Leyland-Jones, B., Goldhirsch, A., Untch, M., Smith, I., ... Gelber, R. D. (2005). Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. New England Journal of Medicine, 353(16), 1659-1672. https://doi.org/10.1056/NEJMoa052306

Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. / Piccart-Gebhart, Martine J.; Procter, Marion; Leyland-Jones, Brian; Goldhirsch, Aron; Untch, Michael; Smith, Ian; Gianni, Luca; Baselga, Jose; Bell, Richard; Jackisch, Christian; Cameron, David; Dowsett, Mitch; Barrios, Carlos H.; Steger, Günther; Huang, Chiun Shen; Andersson, Michael; Inbar, Moshe; Lichinitser, Mikhail; Láng, I.; Nitz, Ulrike; Iwata, Hiroji; Thomssen, Christoph; Lohrisch, Caroline; Suter, Thomas M.; Rüschoff, Josef; Süto, Tamás; Greatorex, Victoria; Ward, Carol; Straehle, Carolyn; McFadden, Eleanor; Dolci, M. Stella; Gelber, Richard D.

In: New England Journal of Medicine, Vol. 353, No. 16, 20.10.2005, p. 1659-1672.

Research output: Contribution to journalArticle

Piccart-Gebhart, MJ, Procter, M, Leyland-Jones, B, Goldhirsch, A, Untch, M, Smith, I, Gianni, L, Baselga, J, Bell, R, Jackisch, C, Cameron, D, Dowsett, M, Barrios, CH, Steger, G, Huang, CS, Andersson, M, Inbar, M, Lichinitser, M, Láng, I, Nitz, U, Iwata, H, Thomssen, C, Lohrisch, C, Suter, TM, Rüschoff, J, Süto, T, Greatorex, V, Ward, C, Straehle, C, McFadden, E, Dolci, MS & Gelber, RD 2005, 'Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer', New England Journal of Medicine, vol. 353, no. 16, pp. 1659-1672. https://doi.org/10.1056/NEJMoa052306
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. New England Journal of Medicine. 2005 Oct 20;353(16):1659-1672. https://doi.org/10.1056/NEJMoa052306
Piccart-Gebhart, Martine J. ; Procter, Marion ; Leyland-Jones, Brian ; Goldhirsch, Aron ; Untch, Michael ; Smith, Ian ; Gianni, Luca ; Baselga, Jose ; Bell, Richard ; Jackisch, Christian ; Cameron, David ; Dowsett, Mitch ; Barrios, Carlos H. ; Steger, Günther ; Huang, Chiun Shen ; Andersson, Michael ; Inbar, Moshe ; Lichinitser, Mikhail ; Láng, I. ; Nitz, Ulrike ; Iwata, Hiroji ; Thomssen, Christoph ; Lohrisch, Caroline ; Suter, Thomas M. ; Rüschoff, Josef ; Süto, Tamás ; Greatorex, Victoria ; Ward, Carol ; Straehle, Carolyn ; McFadden, Eleanor ; Dolci, M. Stella ; Gelber, Richard D. / Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. In: New England Journal of Medicine. 2005 ; Vol. 353, No. 16. pp. 1659-1672.
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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, I.

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

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