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Level of HER2-neu Gene Amplification an Response to Trastuzumab

Conditions
Advanced Breast Cancer
Interventions
Genetic: Fluorescent in-situ hybridization (FISH)
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

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
Arm && Interventions
GroupInterventionDescription
1Fluorescent in-situ hybridization (FISH)HER2-positive advanced breast cancer
Primary Outcome Measures
NameTimeMethod
Association of tumor cytogenetic paremeters with TTP and OS.one year
Secondary Outcome Measures
NameTimeMethod
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.one year

Trial Locations

Locations (1)

Istituto Clinco Humanitas

🇮🇹

Rozzano, Milan, Italy

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