Level of HER2-neu Gene Amplification an Response to Trastuzumab

• Conditions: Advanced Breast Cancer

• Registration Number: NCT00874146
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-01
• Last Update Posted: 2010-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of tumor cytogenetic paremeters with TTP and OS.	one year

Secondary Outcome Measures

Name	Time	Method
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.	one year

Trial Locations

Locations (1)

Istituto Clinco Humanitas; 🇮🇹 Rozzano, Milan, Italy