 3. HER2-positive disease documented as: Immunohistochemistry IHC 3 positive, andor Fluorescence in situ hybridization FISH 2.0, andor gene copy number greater than 6, on previously collected tumor or metastatic site. IHC testing, FISH assays, and gene copy number may all have been performed; however, a positive result from only one of the above is required for eligibility. 