Trastuzumab induced cardiotoxicity
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Adult patients with confirmed HER-2 positive breast cancer (immunohistochemistry score 3 or fluorescence in-situ hybridization positive) who have completed local regional therapy and treatment with trastuzumab or are still on treatment with trastuzumab. •Permanent LVEF =10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or •Symptomatic congestive heart failure defined as NYHA class III/IV •Age 18-80 years. •Signed informed consent •WHO 0-2 Amendement: Add control group: patients without a permanent relative decrease of >=10% from baseline measured by means of echocardiography or MUGA scan and confirmed after 3 weeks after/during treatment with trastuzumab, and/or symptomatic congestive heart failure defined as NYHA class III/IV
Exclusion criteria
Exclusion criteria: •Pre-existing cardiac disease such as heart failure, ischemic and valvular heart disease, arrhythmia or poorly controlled hypertension. •Concomitant inflammatory disease. •Pregnancy/beast feeding. •Allergy against radiopharmaceutical (99m Tc-based tracer) for MUGA scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this pilot study is to assess the neuroadrenergic system in patients with cardiac toxicity due to trastuzumab in order to reveal the pathofysiological mechanisms of trastuzumab induced cardiotoxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is, in case of a positive tendens of abnormal I-MIBG scans in patients with declined LEVFs, to set up a prospective randomized controlled trial for patients with trastuzumab induced cardiotoxiciy in the future. | — |
Countries
Netherlands
Outcome results
None listed