Table 1.

Trials of Adjuvant Trastuzumab for HER2-Positive Breast Cancer

Study and Sample Size for Trial Results	Treatment Schema	DFS HR v Chemotherapy Alone	DFS P	OS HR v Chemotherapy Alone	OS P	Actuarial DFS (%)
Trials of Concurrent Chemotherapy and Trastuzumab
NSABP B-31/NCCTG N9831 (N = 4,045)1	Doxorubicin plus cyclophosphamide followed by paclitaxel v	0.52	< .001	0.61	< .001	73.7*
	Doxorubicin plus cyclophosphamide followed by paclitaxel with trastuzumab → extended trastuzumab†					85.7*
FinHER (N = 232)3	Docetaxel or vinorelbine followed by fluorouracil plus epirubicin plus cyclophosphamide v	0.42	.02	0.41	.07	78‡
	Docetaxel or vinorelbine with trastuzumab followed by fluorouracil plus epirubicin plus cyclophosphamide					89‡
NOAH (N = 235)5§	Doxorubicin plus paclitaxel followed by paclitaxel followed by cyclophosphamide plus methotrexate plus fluorouracil v	0.59	.013	0.62	.114	56‡
	Doxorubicin plus paclitaxel followed by paclitaxel followed by cyclophosphamide plus methotrexate plus fluorouracil, all with trastuzumab → extended trastuzumab†					71‡
BCIRG 006 (N = 3,222)7	Doxorubicin plus cyclophosphamide followed by docetaxel v	0.64	< .001	0.63	< .001	75∥
	Doxorubicin plus cyclophosphamide followed by docetaxel with trastuzumab → extended trastuzumab† v					84∥
	Docetaxel plus carboplatin with trastuzumab → extended trastuzumab†	0.75	.04	0.77	.04	81∥
Trials of Sequential Chemotherapy and Trastuzumab
HERA (N = 3,401)2	Chemotherapy¶ v	0.76	< .001	0.85	.11	72.2*
	Chemotherapy → extended trastuzumab†¶					78.6*
NCCTG N9831 (N = 2,184)6	Doxorubicin plus cyclophosphamide followed by paclitaxel v	0.69	< .001	0.88	.343	71.8∥
	Doxorubicin plus cyclophosphamide followed by paclitaxel → extended trastuzumab†					80.1∥
FNCLCC-PACS04 (N = 528)4	Fluorouracil plus epirubicin plus cyclophosphamide or epirubicin plus docetaxel v	0.86	.41	1.27	NS	78‡
	Fluorouracil plus epirubicin plus cyclophosphamide or epirubicin plus docetaxel → extended trastuzumab†					81‡

Abbreviations: BCIRG, Breast Cancer International Research Group; DFS, disease-free survival; FinHer, Finland Herceptin; FNCLCC, Fédération Nationale des Centres de Lutte Contre le Cancer; HER2, human epidermal growth factor receptor 2; HERA, Herceptin Adjuvant; HR, hazard ratio; NCCTG, North Central Cancer Treatment Group; NOAH, Neo-Adjuvant Herceptin; NS, nonsignificant; NSABP, National Surgical Adjuvant Breast and Bowel Project; OS, overall survival; PACS, Programmes d'Actions Concert ées Sein.

^*4-year DFS.

^†Total duration of trastuzumab = 1 year.

^‡3-year DFS.

^§Chemotherapy administered as neoadjuvant treatment.

^∥5-year DFS.

^¶At least four cycles of standard chemotherapy; 92% of patients received anthracyclines.