National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 and the North Central Cancer Treatment Group (NCCTG) N9831 Trials

  • In 2000, two landmark trials combined results:
    • That compared adjuvant chemotherapy with or without concurrent trastuzumab therapy:
      • In women with surgically removed HER2-positive breast cancer
  • The NSABP B-31 trial:
    • Compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks (group 1) with the same regimen plus 52 weeks of trastuzumab given concurrently with paclitaxel (group 2)
  • The NCCTG N9831 trial:
    • Conducted a similar study that compared three regimens:
      • Group A :
        • Doxorubicin and cyclophosphamide followed by weekly paclitaxel
      • Group B:
        • The same regimen in group A:
          • Followed by 52 weeks of trastuzumab given after paclitaxel
      • Group C:
        • The same regimen in group A:
          • Followed by 52 weeks of trastuzumab:
            • Initiated concurrently with paclitaxel
  • The studies were combined to include:
    • A joint analysis comparing:
      • Groups 1 and group A (the control group) with groups 2 and group C (the trastuzumab group)
      • Group B was excluded
  • Results by 2005 reported:
    • 394 events:
      • Recurrence
      • Second primary cancer
      • Death before recurrence
    • Of these events:
      • 133 were from the trastuzumab group
      • 261 were in the control group:
        • Hazard ratio, 0.48; P<0.0001
    • At 3 years:
      • The absolute difference in DFS between the trastuzumab group and the control group:
        • Was 12%
      • Trastuzumab therapy:
        • Was associated with a 33% reduction in the risk of death (P=0.015)
    • The interim analyses of these trials favored trastuzumab:
      • So strongly that the trials were stopped early and patients in the other arms were offered trastuzumab
    • Long-term analysis of these studies was reported in 2014:
      • At a median follow-up time of 8.4 years:
        • The addition of trastuzumab to chemotherapy:
          • Led to a 37% improvement in OS and
          • An increase in 10-year survival rate:
            • From 75.2% to 84%
        • Outcomes in DFS showed:
          • An improvement of 40% and
          • An increase in the 10-year DFS rate from 62.2% to 73.7%
  • This study showed that all subgroups of HER2-positive patients (small and large tumors, hormone receptor-positive and -negative, low and high number of positive nodes, young and old patients):
    • Benefited from the addition of the targeted anti-HER2 agent:
      • Making trastuzumab an integral drug in the treatment of HER2-positive breast cancer


  1. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol. 2014;32:3744-3752.
  2. Romond E, Perez E, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673-1684.

#Arrangoiz #Surgeon #CancerSurgeon #SurgicalOncologist #BreastSurgeon #BreastCancer

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