Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab
Phase 3
Recruiting
- Conditions
- decrease of the left ventricular ejection fraction (LVEF)1001928010027656
- Registration Number
- NL-OMON34077
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
cytologically or histologically confirmed primary breast cancer
Exclusion Criteria
history of hypersensitivity for the study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> Left ventricular ejection fraction (LVEF)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- NT-proBNP en tropinin T analysis<br /><br>- genotype analysis<br /><br>- electrocardiogram<br /><br>- cardiac questionnaire<br /><br>- New York Heart Association (NYHA)</p><br>