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    Association details:
    Biomarker:HER-2 amplification
    Cancer:HER2 Positive Breast Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Knight Therapeutics Press Release
    Title:

    Knight Therapeutics Announces Health Canada Approval for NERLYNX® (Neratinib) to Treat HER2-Positive Metastatic Breast Cancer

    Published date:
    07/06/2021
    Excerpt:
    Knight Therapeutics Inc...announced today that Health Canada has approved NERLYNX® (neratinib) in combination with capecitabine for the treatment of adult patients with metastatic HER2-overexpressed/amplified breast cancer, who have received two or more prior anti-HER2-based regimens in the metastatic setting. The approval was based on results of the global Phase III NALA trial.
    Secondary therapy:
    capecitabine
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

    Excerpt:
    ...- erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1....
    Trial ID:
    NCT00741260
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Retrospective Observational Study of Patients With Early-stage HER2-positive Breast Cancer, Treated With Neratinib

    Excerpt:
    ...Age will be assessed in years = neratinib initiation date - date of birth`Description of age`Gender will be described in percentage of Male and Female among patients`Description of Gender`BMI will be assessed in kg/m2`Description of BMI`Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea`Menopausal status`Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity`Comorbidities`HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)`HER2 overexpression/amplification testing`Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative`Hormone receptor status`Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer`Primary tumor location`Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other`Primary tumor histology`Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated`Histological grade`Pathologic stage (AJCC classification) of Breast Cancer will be described in percentage of patients with stages 1, 2A, 2B, 3A, 3B, 3C`Pathologic stage (AJCC classification) of Breast Cancer...
    Trial ID:
    NEAR
    More C2 evidence