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

    A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells

    Excerpt:
    ...Histologically confirmed diagnosis of HER-2 negative (i.e. no gene amplification by FISH or IHC 2+ and no amplification by FISH or IHC 0/1+) infiltrating primary breast cancer. ...
    Trial ID:
    2007-002155-17
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer

    Excerpt:
    ...- HER2-overexpressing breast cancer (3+ staining by immunohistochemistry or HER2 gene amplification by fluorescent in situ hybridization [FISH] or silver in situ hybridization [SISH] >= 2.0)...
    Trial ID:
    RTOG 1119
    More C2 evidence
    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:

    Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

    Excerpt:
    ...- Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)...
    Trial ID:
    NCT00089999
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

    Excerpt:
    ...- Documented amplification of ErbB2 by Fluorescence In Situ Hybridization (FISH) in either the primary or metastatic tumor tissue....
    Trial ID:
    NCT00347919
    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:

    Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2

    Excerpt:
    ...- HER2 3+ expression by immunohistochemistry OR > 2-fold (HER2 2+) gene amplification by fluorescence in situ hybridization...
    Trial ID:
    NCT00544804
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

    Excerpt:
    ...- HER2 overexpressing breast cancer defined as 3+ staining by immunohistochemistry, or HER2 gene amplification by FISH...
    Trial ID:
    NCT00470847
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery

    Excerpt:
    ...HER2-positive is defined as HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridization (FISH) (>= 2.0)...
    Trial ID:
    NCT01705340
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases

    Excerpt:
    ...- HER2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with HER2 gene amplification by fluorescent in situ hybridization (FISH), or HER2 gene amplification by FISH alone (in patients whose tumor blocks were...
    Trial ID:
    NCT00098605
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- Unequivocal ErbB2 overexpressing breast cancer, defined as 3+ staining by immunohistochemistry (IHC), or 2+ staining by IHC in conjunction with ErbB2 gene amplification by FISH/CISH, or ErbB2 gene amplification by FISH/CISH alone (in subjects whose tumor blocks were...
    Trial ID:
    NCT00558103
    Less C2 evidence
    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:
    In this study, the anti-proliferative effects of the three TKIs were directly compared using a 115 cancer cell line panel….All three TKIs were effective against HER2-amplified breast cancer models; neratinib showing the most potent activity, followed by tucatinib then lapatinib.
    DOI:
    10.1038/s41416-020-01257-x