Level of HER2-neu Gene Amplification an Response to Trastuzumab

NCT ID: NCT00874146

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-12-31

Brief Summary

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Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.

Detailed Description

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Conditions

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Advanced Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

HER2-positive advanced breast cancer

Fluorescent in-situ hybridization (FISH)

Intervention Type GENETIC

Dual color FISH test to assess ratio of HER2/neu amplification

Interventions

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Fluorescent in-situ hybridization (FISH)

Dual color FISH test to assess ratio of HER2/neu amplification

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive

Exclusion Criteria

* HER2-negative advanced breast cancer Pretreatment with trastuzumab
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 Clinco Humanitas

Rozzano, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Armando Santoro, MD

Role: CONTACT

++39-028224 ext. 4080

Giuseppe Gullo, MD

Role: CONTACT

++39-028224 ext. 4080

Facility Contacts

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Armando Santoro, MD

Role: primary

+39028224 ext. 4080

Giuseppe Gullo, MD

Role: backup

+39028224 ext. 4080

Other Identifiers

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ONC/OSS-03-2008

Identifier Type: -

Identifier Source: org_study_id

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