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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Breast Cancer
    Drug:lapatinib (EGFR inhibitor, HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    Lapatinib (Tyverb) is not recommended for use within NHS Scotland

    Published date:
    06/04/2010
    Excerpt:
    CONTRADICTING EVIDENCE: Lapatinib (Tyverb) is not recommended for use within NHS Scotland...in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress ErbB2 (HER2) and who have progressive disease...
    Secondary therapy:
    capecitabine
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    TYKERB is a kinase inhibitor indicated in combination with:...capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab...
    Secondary therapy:
    capecitabine
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    European Medicines Agency
    Excerpt:
    Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2):...in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy…
    Secondary therapy:
    capecitabine
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...Subjects that have documented ErbB2 amplification based on prior FISH testing or documented ErbB2 overexpression based on prior immunohistochemistry (IHC) with a value of 3+ are eligible, however, archived tumor tissue must be provided for confirmation by the central laboratory....
    Trial ID:
    NCT00347919
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    The Myocet/Lapatinib Study. ICORG 10-03, V5

    Excerpt:
    ...Documented HER2 overexpression (IHC 3+ or FISH or CISH positive) 5....
    Trial ID:
    NCT01495884
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

    Excerpt:
    ...- Tumor that overexpresses ErbB2 defined as 3+ by IHC or FISH +....
    Trial ID:
    NCT00105950
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma (TX or T1-4) of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor;...
    Trial ID:
    NCT00374322
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- Tumor HER2 overexpression...
    Trial ID:
    NCT00544804
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    New
    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
    New
    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
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Lapatinib and Bevacizumab for Metastatic Breast Cancer

    Excerpt:
    ...- Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer....
    Trial ID:
    NCT00444535
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Neoadjuvant GW572016 to Treat Breast Cancer

    Excerpt:
    ...HER2 overexpressing tumors defined as HercepTest score of 3+, or >/- 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >/- 5 (in Dr. ...
    Trial ID:
    NCT00206427
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    New
    Source:
    clinicaltrials.gov
    Title:

    GW572016 In Patients With Advanced Or Metastatic Breast Cancer

    Excerpt:
    ...To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016...
    Trial ID:
    NCT00462956
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer

    Excerpt:
    ...- Advanced or metastatic breast cancer with overexpression of HER2...
    Trial ID:
    NCT01290354
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    New
    Source:
    clinicaltrials.gov
    Title:

    INST 0514C- Biologic Correlative Study: Trial of GW572016 in HER2 Overexpressing Breast Cancer Patients

    Excerpt:
    ...HER2 overexpressing tumors defined as HercepTest score of 3+, or > 10% cells moderately or strongly HER2 positive by other methods, or semi-quantitative score of >5 (in Dr. ...
    Trial ID:
    NCT00455039
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    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
    New
    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
    New
    Source:
    clinicaltrials.gov
    Title:

    Drug Use Investigation for TYKERB Tablet (All Case Investigation)

    Excerpt:
    ...- Patients with HER2 overexpressing inoperable or recurrent breast cancer...
    Trial ID:
    NCT01332396