Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Istituto Clinico Humanitas

Status: Completed

Conditions: Breast Cancer

Treatments: Genetic: Gene mutation analyses and FISH

Study type: Observational

Funder types: Other

Identifiers

NCT00740532

ONC/OSS-01/2007

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

Observation

Description:

Breast cancer patients treated with Herceptin-based therapy

Treatment:

Genetic: Gene mutation analyses and FISH