cancer oncology
Conditions
Interventions
 
The study population consists of female breast cancer patients whom are treated in the adjuvant setting with a combination of doxorubicine and cyclofosfamide followed by paclitaxel, based on SAZ proto
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Female - Age >= 18 years - Patients that are to be treated for breast cancer in the neoadjuvant or adjuvant setting with one of the following treatment schedules, in accordance with SAZ protocols: o Doxorubicine and cyclofosfamide q2w for 4 cycles, followed by paclitaxel q1w for 12 cycles o Doxorubicine and cyclofosfamide q3w for 4 cycles, followed by paclitaxel q1w - Informed consent form (ICF) signed prior to participation in the study.
Exclusion criteria
Exclusion criteria: Patients that already started treatment in one of the above described protocols are not eligible for inclusion, since a baseline sample is necessary.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of the dynamics of hs-cTnI and hs-TnT release during and after anthracycline treatment (doxorubicine in combination with cyclofosfamide) in breast cancer patients in order to determine the optimal sampling time point, most reflective of the (total) cardiac damage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the relation between summary parameters for troponin exposure (Cmax, relative increase of troponin from baseline and AUC) and cardiotoxicity, defined as persistent LVEF decline and/or development of symptomatic heart failure. (This endpoint is explorative) | — |
Countries
Netherlands
Contacts
Public ContactA.H.M. de Vries Schultink
St. Antonius Ziekenhuis
Outcome results
None listed