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Measurable or evaluable metastatic disease documented by radiograph, computerized tomography (CT) scan, positron emission tomography (PET)/CT scan, magnetic resonance imaging (MRI), bone scan, or physical examination was required. Each patient was required to have at least one bi-dimensionally measurable lesion that had not been irradiated with at least one diameter being ≥10 mm for liver, lung, skin lesions, and ≥15 mm for lymph node metastases. Biopsy of recurrent site(s) was not required. Biopsy of accessible sites before and after HER2 BATs was an option.
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