Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients|
- Association of a specific biomarker with response to Herceptin-based therapy [ Time Frame: Response after two months of treatment ] [ Designated as safety issue: No ]
- Association of a specific biomarker with time to progression survival and patient's characteristics [ Time Frame: At the end of enrollment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Paraffine embedded tumor sections
|Study Start Date:||October 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Breast cancer patients treated with Herceptin-based therapy
Genetic: Gene mutation analyses and FISH
FISH and mutation analyses of multiple genes