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    Association details:
    Biomarker:HER-2 positive
    Cancer:HER2 Positive Breast Cancer
    Drug:Herwenda (trastuzumab biosimilar) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    EirGenix Press Release
    Title:

    POSITIVE PHASE III CLINICAL RESULTS FOR EIRGENIX’S PROPOSED TRASTUZUMAB BIOSIMILAR

    Published date:
    03/23/2021
    Excerpt:
    EirGenix, Inc...announced that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint. EG12014 has shown equivalent efficacy to Herceptin® in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile....This phase III clinical trial is a multi-national, multi-center, randomized, double-blinded study involving female with early, HER2-positive breast cancer.
    Trial ID:
    EGC002
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
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    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

    Excerpt:
    ...HER2 positive tumor, defined as 3+ score by IHC or fluorescence positive by FISH, as confirmed by central laboratory....
    Trial ID:
    EGC002