Table 1.

Characteristics of studies that evaluated different schemes of CET in patients with HER−2+ locally advanced or metastatic breast cancer

Study	Design	n HER-2+	Patients	Analysis	Primary end point
Chemotherapy with or without lapatinib
Guan et al11	Randomized, double-blind, placebo-controlled, multicenter	444	Metastatic breast cancer	ITT	OS
Di Leo et al29	Randomized, double-blind, placebo-controlled, multicenter	86	Locally advanced or metastatic breast cancer	ITT	PFS
Geyer et al7 Cameron et al27,28	Randomized, nonblinded, open-label, multicenter	324	Locally advanced or metastatic breast cancer	ITT	PFS
Endocrine therapy with or without lapatinib
Johnston et al9 Schwartzberg et al30	Randomized, double-blind, placebo-controlled, multicenter	219	Locally advanced or metastatic breast cancer	ITT	TTP

Abbreviations: ITT, intention-to-treat; OS, overall survival; PFS, progression free survival; TTP, time to progression; HER-2, human epidermal growth factor receptor-2; CET, chemotherapy or endocrine therapy.