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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Breast Cancer
    Drug:Herzuma (trastuzumab-pkrb) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    HERZUMA is a HER2/neu receptor antagonist indicated for: the treatment of HER2-overexpressing breast cancer...as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel...as part of a treatment regimen with docetaxel and carboplatin...In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer.
    Secondary therapy:
    bisphosphonate bound paclitaxel; carboplatin + docetaxel; ACT + doxorubicin hydrochloride + cyclophosphamide; docetaxel + doxorubicin hydrochloride + cyclophosphamide
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    This study will investigate the similarity of CT-P6 and Herceptin, both in combination with paclitaxel, in terms of efficacy (how well it treats your tumour), pharmacokinetics (the levels of the study medication that can be measured in your blood) and safety (side effects) in patients with metastatic breast cancer.

    Excerpt:
    ...Have a strong Her 2 over-expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in-situ hybridisation (FISH) or chromogenic in-situ hybridisation (CISH) result.5. ...
    Trial ID:
    2009-016197-33
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Evaluate Safety, Efficacy and Pharmacokinetics

    Excerpt:
    ...- Have a Her 2 over-expression...
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Demonstrate Efficacy and Safety of Metastatic Breast Cancer

    Excerpt:
    ...- Have a Her 2 over-expression...