Pivotal Studies and Efficacy Data

The following four phase III trials involved more than 10,000 patients and demonstrated a significant reduction in the risk of recurrence when 12 months of Herceptin was used with standard adjuvant therapy. The trials were varied in study design and in the specific treatment regimen administered.

  • The BCIRG 006 Trial
  • This clinical trial, conducted by the Breast Cancer International Group (BCIRG), evaluated the efficacy and safety of 2 Herceptin-containing regimens (TCH and AC→TH) vs a control (AC→T).
  • Joint Analysis of NSABP B-31 and NCCTG N9831
  • Two cooperative group trials (NSABP B-31 and NCCTG N9831) with similar protocols evaluated the efficacy of adding 12 months of Herceptin to standard therapy in the adjuvant treatment of HER2+ breast cancer. Results were combined in a Joint Analysis.
  • The HERA Trial
  • The HERA trial, an international multicenter, randomized, open-label, controlled clinical trial conducted by the Breast International Group (BIG), evaluated the effect of 1 and 2 years of Herceptin in the adjuvant treatment of HER2+ breast cancer. The primary endpoint was disease- free survival (DFS).


Herceptin® (trastuzumab)Herceptin® (trastuzumab)

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