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ong-term safety of trastuzumab in patients with HER2-positive breast cancer

Completed
Conditions
decrease of left ventricular ejection fraction
10019280
10027656
Registration Number
NL-OMON33506
Lead Sponsor
Antoni van Leeuwenhoek Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Strongly HER2-positive breast cancer, defined as an immunohistochemistry score of 3+ using the HercepTestTM, or gene amplification by fluorescence in situ hybridization, or chromogenic in situ hybridization (CISH)

Exclusion Criteria

Pregnancy or breast feeding

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- Left ventricular ejection fraction (LVEF)</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- NT-proBNP en troponin T analysis<br /><br>- New York Heart Association (NYHA)<br /><br>- genotype analysis<br /><br>- electrocardiogram</p><br>
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