Table 2: Randomized trials with neoadjuvant lapatinib versus trastuzumab or lapatinib versus trastuzumab versus lapatinib plus trastuzumab.

Study (ref.)No. of ptsClinical stageNeoadjuvant chemotherapyNeoadjuvant anti-HER2 therapypCR rate (%)cCR (%)Breast-conserving surgery rate (%)

NeoALTTO [12],
phase III
455T > 2 cm, any NWeekly P (12 w)(i) Trastuzumab 4 → 2 mg/kg/w
(ii) Lapatinib 1500 mg/d
(iii) Lapatinib 1000 mg/d + trastuzumab 2 mg/kg/w
28%
20%
47%
NR39%
43%
41%
GeparQuinto [13],
phase III
615cT3/4a–d or HR− or cT2cN+ HR+ or cT1pNSLN+ HR+EC (4 c) → Doc (4 c)(i) Trastuzumab 8 → 6 mg/kg/3 w
(ii) Lapatinib 1250 mg/d (adjustment to 1000 mg/d)
44%
30%
33%
28.5%
64%
59%
CHER-LOB [14],
phase II
121II–IIIAWeekly P (12 w) → FEC (4 c)(i) Trastuzumab 4 → 2 mg/kg/w
(ii) Lapatinib 1500 mg/d
(iii) Lapatinib 1000 mg/d + trastuzumab 2 mg/kg/w
25%
26%
47%
NR67%
58%
69%
NSABP B-41 [15],
phase III
464T > 2 cm, any NAC (4 c) → P (D1, 8, 15, 28; 4 c)(i) Trastuzumab 4 → 2 mg/kg/w
(ii) Lapatinib: 1250 mg/d
(iii) Lapatinib 750 mg/d + trastuzumab 2 mg/kg/w
49%
47%
60%
82%
70%
77%
54%
46%
50%
Holmes et al. [16],
phase II
100II-IIIFEC75 (4 c) → weekly P (12 w)(i) Trastuzumab 4 → 2 mg/kg/w
(ii) Lapatinib 1250 mg/d
(iii) Lapatinib 750 mg/d + trastuzumab 2 mg/kg
54%
45%
74%
NRNR
GEICAM 2006-14 [17],
phase II
99T > 2 cm or N+ any TEC (4 c) → Doc (4 c)(i) Trastuzumab: 8 → 6 mg/kg/3 w
(ii) Lapatinib: 1250 mg/d
48%
24%
NR58%
58%

pCR: pathological complete response; cCR: clinical complete response; NR: not reported; HR: hormonal receptors; EC: Epirubicin + Cyclophosphamide; Doc: Docetaxel; FEC: 5fluoro-uracile-epirubicine-cyclophosphamide; AC: adriamycin-cyclophosphamide.