Real-world performance of HER2 testing--National Surgical Adjuvant Breast and Bowel Project experience

J Natl Cancer Inst. 2002 Jun 5;94(11):852-4. doi: 10.1093/jnci/94.11.852.


Trastuzumab (Herceptin) provides clinical benefits for patients diagnosed with advanced breast cancers that have overexpressed the HER2 protein or have amplified the HER2 gene. The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-31 is designed to test the advantage of adding Herceptin to the adjuvant chemotherapeutic regimen of doxorubicin and cyclophosphamide followed by paclitaxel (Taxol) in the treatment of stage II breast cancer with HER2 overexpression or gene amplification. Eligibility is based on HER2 assay results submitted by the accruing institutions. We conducted a central review of the first 104 cases entered in this trial on the basis of immunohistochemistry (IHC) results. We found that 18% of the community-based assays, which were used to establish the eligibility of patients to participate in the B-31 study, could not be confirmed by HercepTest IHC or fluorescence in situ hybridization (FISH) by a central testing facility. This report provides a snapshot of the quality of HER2 assays performed in laboratories nationwide.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics
  • Breast Neoplasms / metabolism*
  • Breast Neoplasms / surgery
  • Chemotherapy, Adjuvant
  • Clinical Trials as Topic / methods
  • Contraindications
  • Diagnostic Errors
  • Gene Amplification
  • Humans
  • Immunohistochemistry
  • In Situ Hybridization, Fluorescence
  • Patient Selection*
  • Quality Assurance, Health Care
  • Receptor, ErbB-2 / analysis*
  • Receptor, ErbB-2 / genetics
  • Receptor, ErbB-2 / metabolism
  • Reproducibility of Results
  • Trastuzumab


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Receptor, ErbB-2
  • Trastuzumab