Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study.

In terms of HER2 status evaluated by IHC and FISH, as expected, ORR and CBR were higher in the HER2-positive subgroup, althougha small number of subjects had IHC or FISH negative tumors. ORR was similar in EGFR IHC 0 and 2 + subgroups; there was a possible trend of a correlation between EGFR status and tumor response; however, inference testing was not performed.

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