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

    A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval

    Excerpt:
    ...Metastatic breast cancer that over-expresses ErbB2 OR Recurrent, advanced, or metastatic solid tumor malignancy (including breast cancer that does...
    Trial ID:
    NCT01328054
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

    Excerpt:
    ...- Any lymph node status, hormone receptor status, and level of erbB2 expression...
    Trial ID:
    NCT00343759
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib and Circulating Tumor Cells in Breast Cancer

    Excerpt:
    ...EGFR and/or HER-2 expression on the primary tumor is...
    Trial ID:
    NCT00694252
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

    Excerpt:
    ...- Had tumors that overexpress ErbB2 defined as 3+ by IHC or c-erbB2 gene amplification by FISH (ErbB2 expression/amplification must be documented prior to study entry; however, a tumor tissue sample must be sent to a central laboratory for subsequent re-analysis of ErbB2 status);...
    Trial ID:
    NCT00374322
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

    Excerpt:
    ...- Subjects must meet the following criteria regarding ErbB2 expression (defined by the following status before undergoing trastuzumab therapy.) Patients with ErbB2 overexpression:...
    Trial ID:
    NCT00320411
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

    Excerpt:
    ...- The DCIS cells must have high expression of human epidermal growth factor receptor 2 (erbB2) (3+ by immunohistochemical staining or amplification by fluorescence in situ hybridization [FISH]), and/or have detectable expression of epidermal growth factor receptor (EGFR) (1+ or more by immunohistochemical staining)...
    Trial ID:
    NCT00555152
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

    Excerpt:
    ...Metastatic breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive)and the subject has received prior therapy including an anthracycline, a taxane, and trastuzumab OR Recurrent, advanced, or metastatic solid tumor malignancy (including breast cancer that does...
    Trial ID:
    NCT00996762
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients

    Excerpt:
    ...- Metastatic, histologically confirmed breast cancer that over-expresses ErbB2 (3+ by IHC; FISH or CISH positive)....
    Trial ID:
    NCT00821054
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

    Excerpt:
    ...Patients will remain on study based on local ErbB2 expression results....
    Trial ID:
    NCT00558103
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    Serum Human Epidermal Growth Factor 2 Extracellular Domain as a Predictive Biomarker for Lapatinib Treatment Efficacy in Patients With Advanced Breast Cancer

    Excerpt:
    Lapatinib PFS benefit is independently predicted by higher sHER2 values (HR per 10-ng/mL increase in sHER2: lapatinib-containing therapies, 1.009 v nonlapatinib-containing therapies, 1.044; P(interaction) < .001) and by positive tHER2 (HR [lapatinib v nonlapatinib]: tHER2 positive, 0.638 v tHER2 negative, 0.940; P(interaction) = .001).
    DOI:
    10.1200/JCO.2015.62.4767