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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lethal Congenital Contracture Syndrome 2 Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gene mutation analyses and FISH

Genetic

FISH and mutation analyses of multiple genes

Primary outcomes

Association of a specific biomarker with response to Herceptin-based therapy

Time frame: Response after two months of treatment

Secondary outcomes

Association of a specific biomarker with time to progression survival and patient's characteristics

Time frame: At the end of enrollment

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2010
First posted: Aug 25, 2008
Registry last updated: Sep 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed