Study Design

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This is a randomized open-label, phase 2 study designed to evaluate PFS (primary endpoint) between the experimental and comparator arms within two distinct HER2 IHC groups.  Patients with advanced HER2-expressing distal esophagus, GE junction or stomach cancers who have failed one standard fluoropyrimidine/platinum-based frontline systemic therapy (with or without trastuzumab) in the Traditional HER2 Group, or without trastuzumab in the Non-Traditional HER2 Group are eligible.  A schematic representation of the study design is presented in Figure 11. 

Figure 11. Study Design 


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