In a recent global phase I clinical trial in predominantly Western Caucasian patients with HER2-overexpressing breast cancer or gastric cancer, and with ESCC or SCCHN, regardless of HER2 status (NCT01598077), single-agent LJM716 was well tolerated up to a recommended dose (RD) of 40 mg/kg [17]. This evidence concerns the gene ERBB2 and breast carcinoma.