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NCT00874146 Clinical Trial

Level of HER2-neu Gene Amplification an Response to Trastuzumab

Advanced Breast Cancer Clinical Trial

Official title:
Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00874146
Other study ID # ONC/OSS-03-2008
Secondary ID
Status Recruiting
Phase N/A
First received March 26, 2009
Last updated September 1, 2010
Start date March 2009
Est. completion date December 2009

Study information
Verified date September 2010
Source Istituto Clinico Humanitas
Contact Armando Santoro, MD
Phone ++39-028224
Email armando.santoro@humanitas.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• Fluorescent in-situ hybridization (FISH)
Dual color FISH test to assess ratio of HER2/neu amplification

Locations
Country Name City State
Italy Istituto Clinco Humanitas Rozzano Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association of tumor cytogenetic paremeters with TTP and OS. one year No
Secondary Association of cytogenetic parameters evalued by FISH test and patients' characteristics. one year No
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