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

NCT ID: NCT00740532

Last Updated: 2010-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observation

Breast cancer patients treated with Herceptin-based therapy

Gene mutation analyses and FISH

Intervention Type GENETIC

FISH and mutation analyses of multiple genes

Interventions

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Gene mutation analyses and FISH

FISH and mutation analyses of multiple genes

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Istituto Clinico Humanitas

Principal Investigators

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Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Istituto Clinico Humanitas

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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ONC/OSS-01/2007

Identifier Type: -

Identifier Source: org_study_id

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