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    Association details:
    Biomarker:HER-2 mutation
    Cancer:Breast Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

    Excerpt:
    ...for Pre-registration (for patients with unknown HER2 mutation status to have tumor tissue screened centrally by Washington University GPS laboratory):...
    Trial ID:
    NCT01670877
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

    Excerpt:
    ...- Must be able to provide blood sample(s) for HER2 mutation testing...
    Trial ID:
    HER-Seq
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    AACR 2021
    Title:

    CT026 - A phase II trial of neratinib (NER) or NER plus fulvestrant (FUL) (N+F) in HER2 mutant, non-amplified (HER2mut) metastatic breast cancer (MBC): Part II of MutHER

    Published date:
    03/10/2021
    Excerpt:
    NER, or N+F, is active for HER2mut MBC with good tolerability. Adding trastuzumab at PD induced further response, supporting dual HER2 blockade for HER2mut MBC.
    Secondary therapy:
    fulvestrant
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    AACR 2021
    Title:

    CT026 - A phase II trial of neratinib (NER) or NER plus fulvestrant (FUL) (N+F) in HER2 mutant, non-amplified (HER2mut) metastatic breast cancer (MBC): Part II of MutHER

    Published date:
    03/10/2021
    Excerpt:
    NER, or N+F, is active for HER2mut MBC with good tolerability. Adding trastuzumab at PD induced further response, supporting dual HER2 blockade for HER2mut MBC.
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Br J Cancer
    Title:

    Comparative analysis of drug response and gene profiling of HER2-targeted tyrosine kinase inhibitors

    Published date:
    01/21/2021
    Excerpt:
    The anti-proliferative effects of neratinib, lapatinib, and tucatinib were examined across a panel of 115 cancer cell lines...Neratinib displayed the greatest anti-proliferative activity against HER2-mutant and EGFR-mutant models compared to the other HER2-targeted TKIs and was the most potent of the three TKIs in breast cancer models.
    DOI:
    10.1038/s41416-020-01257-x