, Volume 70, Issue 2, pp 215-239
Date: 17 Sep 2012


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Trastuzumab (Herceptin®) is a humanized IgG1 κ monoclonal antibody, specifically targeted against the extracellular domain of the human epidermal growth factor receptor 2 (HER2), and is indicated for the treatment of HER2-positive early or metastatic breast cancer. This review discusses the available data regarding its use in early breast cancer.

Trastuzumab, when administered concurrently with chemotherapy regimens, consistently prolonged disease-free survival (primary endpoint) and overall survival (secondary endpoint) in patients with HER2-positive early breast cancer in well designed trials; studies evaluating sequential trastuzumab treatment have produced mixed results for these endpoints. Further study is required to ascertain the optimal trastuzumab treatment regimen, including the duration of treatment. Trastuzumab was generally well tolerated when added to, or administered following, a chemotherapy regimen in clinical trials. While cardiac adverse events, such as a decreased left ventricular ejection fraction and congestive heart failure, are a concern, these effects are treatable and appear to be mostly reversible. Thus, trastuzumab is a valuable component of treatment regimens for HER2-positive early breast cancer.

Various sections of the manuscript reviewed by: E. Briasoulis, Department of Medical Oncology, University of Ioannina Medical School, Ioannina, Greece; A.M. Brufsky, Magee-Womens Hospital, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA; A.U. Buzdar, Department of Breast Medical Oncology, MD Anderson Cancer Center, University of Texas, Houston, Texas, USA; E. de Azambuja, Medical Oncology Clinic, Breast Data Centre, Institut Jules Bordet, Brussels, Belgium; W. Jacot, Val d’Aurelle Clinic, Montpellier, France; E.A. Perez, Division of Hematology/Oncology, Mayo Clinic, Jacksonville, Florida, USA.

Data Selection

Data Selection Sources: Medical literature published in any language since 1980 on ‘trastuzumab’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.
Search strategy: MEDLINE, EMBASE and AdisBase search terms were ((‘trastuzumab’) and (‘early breast cancer’)) or (((‘trastuzumab’) and (‘breast cancer’)) not (‘advanced’ or ‘metastatic’)). Searches were last updated 7 January 2010.
Selection: Studies in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer who received adjuvant treatment with trastuzumab. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.
Index terms: Trastuzumab, HER2-positive, early breast cancer, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.
An erratum to this article is available at http://dx.doi.org/10.2165/11596220-000000000-00000.