Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Completed
- Conditions
- Breast Cancer
- Interventions
- Genetic: Gene mutation analyses and FISH
- Registration Number
- NCT00740532
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 11
Inclusion Criteria
- Hystological diagnosis of breast cancer
- Availability of tumor tissue
- Availability to assess the response to Trastuzumab according to RECIST criteria
- Availability of clinical data
Exclusion Criteria
- Unavailability of tumor tissue
- Impossibility to assess the response to Trastuzumab according to RECIST criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation Gene mutation analyses and FISH Breast cancer patients treated with Herceptin-based therapy
- Primary Outcome Measures
Name Time Method Association of a specific biomarker with response to Herceptin-based therapy Response after two months of treatment
- Secondary Outcome Measures
Name Time Method Association of a specific biomarker with time to progression survival and patient's characteristics At the end of enrollment
Trial Locations
- Locations (1)
Istituto Clinico Humanitas
🇮🇹Rozzano, Milan, Italy