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Table 2 Reported randomised phase III trials with neoadjuvant trastuzumab

From: Are we HER-ting for innovation in neoadjuvant breast cancer trial design?

      pCR rate, percentage (95% CI)
Reference Number of patients Patient population Design HER2 assessment No H With H P value
Buzdar et al., 2005 [11], 2007 [12] 42 65% T2 40% N0/57% N1 P → FEC vs. P + H → FEC + H IHC 3+ or FISH+ 26 (9–51) 65 (43–84) NS
Gianni et al., 2007 [13] 228 60% T4 85% N+ AP → P → CMF vs. AP + H → P + H → CMF + H IHC 3+ or FISH 23 (NR) 43 (NR) 0.002
Untch et al., 2008 [15] 453 NA EC → D or EC → DX or EC → D → X vs. EC → D + H or EC → DX + H or EC → D + H → X + H NA 20 (NR) 41 (NR) <0.001
  1. C, cyclophosphamide; CI, confidence interval; D, docetaxel; E, epirubicin; F, 5-fluoruracil; FISH, fluorescence in situ hybridization; H, trastuzumab; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; M, methotrexate; N, nodal status; NA, not applicable; NR, not reported; NS, not significant; P, paclitaxel; pCR, pathologic complete response; T, tumour size; X, capecitabine.