Breast Cancer
Conditions
Keywords
EGFR, HER-2, HER-3, MET, KRAS
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.
Interventions
GENETICGene mutation analyses and FISH
FISH and mutation analyses of multiple genes
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association of a specific biomarker with response to Herceptin-based therapy | Response after two months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Association of a specific biomarker with time to progression survival and patient's characteristics | At the end of enrollment |
Countries
Italy
Outcome results
None listed