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    Association details:
    Biomarker:ER positive
    Cancer:HER2 Positive Breast Cancer
    Drug:Nerlynx (neratinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ESMO.org
    Title:

    Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

    Published date:
    06/04/2019
    Excerpt:
    Extended adjuvant anti-HER2 therapy with neratinib in patients who completed 1 year of trastuzumab demonstrated additional improvement in DFS, in particular in the ER-positive/ HER2-positive subgroup, albeit at the cost of significant toxicity, mostly diarrhoea.
    DOI:
    10.1093/annonc/mdz173
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

    Excerpt:
    ...For ER positive breast cancer patients:...
    Trial ID:
    NCT04965064
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    Less C2 evidence
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    SABCS 2022
    Title:

    Neratinib vs. Trastuzumab plus Ribociclib in ERBB2-positive breast cancer: Preclinical mechanistic efficacy study

    Published date:
    11/22/2022
    Excerpt:
    Here, we evaluate the mechanistic efficacy and comparability of neratinib (N) (an irreversible pan-ERBB tyrosine kinase inhibitor) in combination with fulvestrant (F) against ribociclib (R) plus trastuzumab (T) in HER2-amplified breast cancer cells....HER2+ breast cancer cell lines...BT474 (ER+), SKBR3 (ER-), and MDA-MB453 (ER-, PIK3CA mutated [H1047R]) were used for the study....BT474 and MDA-MB453 were highly sensitive to N (+F), and high growth inhibition was evident at lower doses (< 20 nM).