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

Breast Cancer Research

Table 2 Reported randomised phase III trials with neoadjuvant trastuzumab

					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

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.

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