English to Russian Medical Medical: Pharmaceuticals

Subjects will have HER2 status determined by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in samples prior to enrollment. Additionally, tumor biopsies performed while the subject is on study should be made available to the Sponsor, if feasible. For example, if a biopsy on residual tumor is performed at the EOT of at progression, a sample will be collected (if residual tumor is available). Blood samples for biomarker assay will be drawn at the Screening Visit and at EOT)/in situ hybridization (ISH) in samples prior to enrollment. HER2 status will be determined prior to enrollment to ensure population is standardized using a single test and a single scoring algorithm due to known historical changes in scoring algorithm and known variability observed in local HER2 testing.