cardiac injury cardiotoxicity
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Female patients with breast cancer, >= 18 years old at the time of breast cancer diagnosis -(Neo)adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide (TAC) completed minimally one year before inclusion and maximally nine years before.
Exclusion criteria
Exclusion criteria: -Evidence of breast cancer recurrence or metastatic disease -Evidence of heart disease at the time of breast cancer diagnosis -Evidence of renal failure at the time of cardiac evaluation -Pregnant or lactating -Participation in a research protocol with ionizing radiation within one year before inclusion. -Evidence of Diabetes Mellitus or Parkinson*s Disease -Evidence of an MIBG-accumulating tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| left ventricular ejection fraction | — |
Secondary
| Measure | Time frame |
|---|---|
| -clinical symptoms or signs of heart failure (tachycardia, dyspnea, orthopnea, edema, S3 gallop) -other echocardiographic parameters to indicate systolic and diastolic function, left ventricular dimension and left ventricular mass -electrocardiographical signs of ischemia or arrhytmia -MIBG uptake below normal -Troponin-I, NT-pro-BNP, cytokine and adhesion molecule levels above normal | — |
Countries
Netherlands