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    Association details:
    Biomarker:HER-2 amplification
    Cancer:HER2 Positive Breast Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) +
    Kadcyla (ado-trastuzumab emtansine) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

    Excerpt:
    ...- Over-expression by immunohistochemistry (IHC) with score of 3+ (in > 30% of invasive tumor cells) AND/OR HER2 gene amplification (> 6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene copies to chromosome 17 signals] of ≥ 2.0) -...
    Trial ID:
    NCT01494662
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Safety and Efficacy of T-DM1 Plus Neratinib in Patients With Metastatic HER2-Positive Breast Cancer: NSABP Foundation Trial FB-10

    Excerpt:
    We evaluated the safety, tolerability, and efficacy of ado-trastuzumab emtansine (T-DM1) plus neratinib in patients who progressed on trastuzumab plus pertuzumab...Deep and more durable responses occurred in patients with cell-free DNA ERBB2 amplification.
    DOI:
    10.1200/JCO.19.00858
    Trial ID:
    NCT02236000