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Clinical Trials/NCT00874146
NCT00874146
Unknown
Not Applicable

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.

Istituto Clinico Humanitas1 site in 1 country100 target enrollmentMarch 2009
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ConditionsAdvanced Breast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced Breast Cancer
Sponsor
Istituto Clinico Humanitas
Enrollment
100
Locations
1
Primary Endpoint
Association of tumor cytogenetic paremeters with TTP and OS.
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2009
Last Updated
15 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Istituto Clinico Humanitas

Eligibility Criteria

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

Outcomes

Primary Outcomes

Association of tumor cytogenetic paremeters with TTP and OS.

Time Frame: one year

Secondary Outcomes

  • Association of cytogenetic parameters evalued by FISH test and patients' characteristics.(one year)

Study Sites (1)

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