1. Figure 1. Adjuvant trastuzumab study designs
NCCTG N9831
1 year trastuzumab
4 x AC
12 x paclitaxel 90 mg/m2
HER2+
(IHC or FISH)
NSABP B-31
HER2+
1 year trastuzumab
4 x AC
4 x paclitaxel 175 mg/m2 2
(IHC or FISH)
BCIRG 006
HER2+
4 x AC
60/600 mg/m2
4 x docetaxel
100 mg/m2
6 x docetaxel and carboplatinum
75 mg/m2
AUC 6
1 year trastuzumab
N=3222
1 year trastzumab
AC→T
AC→TH
TCH
(FISH)
HERA
2 years trastuzumab
HER2+
(IHC or FISH)
Accepted CT:
AC, EC, FAC,
FEC, ET, AT,
CMF
1 year trastuzumab
Observation

2. Table 1. Overview of the trial populations in early breast cancer trastuzumab studies
Stage I-IIIA, MO, invasive adenocarcinoma
Trial
NSABP B-31
NCCTG
BCIRG 006
HERA
N0(T1a T1b T1c) 
   N+ 
IHC 
FISH 
Randomized
Prechemo
Postchemo EF
>50%
>55%
N0 node negative; N+ node positive;IHC immunohistochemistry; FISH fluorescent in situ hybridization; EF left ventricular ejection fraction required for study entry

3. Table 2. Efficacy in early breast cancer trastuzumab studies
NSABP-B31 NCCTG N9831 combined analysis
BCIRG 006
HERA
ACTH TCH
Regimen
Follow-up
Evaluable pts
HR for DFS
HR for DDFS
HR for OS
Concurrent
2 years
3351
Concurrent
2 years
3222
Sequential
1 year
3387
0.48
0.47
0.67
2p=3x10-12
2p=8x10-10
2p=0.015
0.49 NR
0.61
p<0.0001
p=0.0002
0.54
0.51
0.76
p<0.0001
p=0.26
TCH = docetaxel, carboplatinum, trastuzumab; TH = docetaxel, trastuzumab
HR = hazard ratio; DFS = disease-free survival; DDFS = distant DFS; OS = overall survival

4. Table 3. Cardiac safety in early breast cancer trastuzumab studies
NSABP-B31
NCCTG N9831
HERA
BCIRG 006
AC P
AC PH
AC P
AC PH
ACP H
Nil
H 1 year
AC T
AC TH
TCH
CHF, n (%)
Cardiac death, n
4 (0.8) 1
31 (4.1)
0 (0.3) 1
20 (3.5) 1
16 (2.5) 1
0 (0) 1
9 (0.5)
3 (0.3)
17 (1.7)
4 (0.4)
NSABP (from JCO cardiotoxicity paper) and NCCTG (from SABCS 2005 poster) report cumulative rates, 006 reports raw rates
H = Trastuzumab; P = paclitaxel; T = docetaxel; TCH = docetaxel, carboplatinum, trastuzumab; CHF = New York Heart Association Class 3-4 congestive heart failure