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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:HER2 Positive Breast Cancer
    Drug:Trazimera (trastuzumab-qyyp) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Published date:
    07/26/2018
    Excerpt:
    Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):...in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable....in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease….in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin….in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter....Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
    Secondary therapy:
    docetaxel; carboplatin + docetaxel; Chemotherapy; paclitaxel
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Published date:
    07/26/2018
    Excerpt:
    Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):…as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease….Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Br J Cancer
    Title:

    PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

    Published date:
    12/20/2018
    Excerpt:
    ...there were no notable differences between groups in progression-free survival (median: 12.16 months in the PF-05280014 group vs. 12.06 months in the trastuzumab-EU group; 1-year rate: 54% vs. 51%) or overall survival (median: not reached in either group; 1-year rate: 89.31% vs. 87.36%)....PF-05280014 plus paclitaxel demonstrated equivalence to trastuzumab-EU plus paclitaxel in terms of ORR.
    Secondary therapy:
    paclitaxel
    DOI:
    10.1038/s41416-018-0340-2
    Trial ID:
    REFLECTIONS B327-02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)

    Excerpt:
    ...- Documentation of HER2 gene amplification or overexpression....
    Trial ID:
    REFLECTIONS B327-02
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)

    Excerpt:
    ...- Histologically confirmed HER2 overexpressing invasive breast cancer....
    Trial ID:
    REFLECTIONS B327-04