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    HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with adenocarcinoma of the stomach, including the gastroesophageal junction. HercepTest specifically demonstrates overexpression of HER2 protein. HercepTest is indicated as an aid in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered.
    Cancer:
    Breast Cancer, Gastric Cancer, Gastroesophageal Cancer
    Gene:
    HER-2 (Human epidermal growth factor receptor 2)
    Drug:
    Herceptin (trastuzumab), Kadcyla (ado-trastuzumab emtansine), Perjeta (pertuzumab)
    Method:
    Immunohistochemistry (IHC)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    09/25/98
    BC
    HER-2
    trastuzumab
    FDA
    10/20/10
    GC
    HER-2
    trastuzumab
    FDA
    GC
    06/08/12
    BC
    HER-2
    pertuzumab
    FDA
    02/22/13
    BC
    HER-2
    ado-trastuzumab e...
    FDA
    Confirmatory trial(s)
    HERA
    ,
    NCT00045032
    |
    NEJM Journal Watch
    EMILIA
    ,
    NCT00829166
    |
    NEJM Journal Watch
    CLEOPATRA
    ,
    NCT00567190
    |
    NEJM Journal Watch