Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients - Full Text View

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00740532

Purpose

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.

Condition	Intervention
Breast Cancer	Genetic: Gene mutation analyses and FISH

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

Association of a specific biomarker with response to Herceptin-based therapy [ Time Frame: Response after two months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Biospecimen Description:

Paraffine embedded tumor sections

Enrollment:	45
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Observation Breast cancer patients treated with Herceptin-based therapy	Genetic: Gene mutation analyses and FISH FISH and mutation alalyses of multiple genes

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Breast cancer patients treated with Herceptin-based therapy

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740532

Locations

Italy, Milan
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

Principal Investigator:

Armando Santoro, MD

Istituto Clinico Humanitas

More Information

Responsible Party:	Istituto Clinico Humanitas ( Armando Santoro, MD )
Study ID Numbers:	ONC/OSS-01/2007
Study First Received:	August 22, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740532
Health Authority:	Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:

EGFR, HER-2, HER-3, MET, KRAS

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009