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.

Snoj et al. Breast Cancer Research 2009 11:201   doi:10.1186/bcr2209