Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer|
- difference in LVEF (Left Ventricular Ejection Fraction) [ Time Frame: from one to six years from adjuvant radiotherapy for early breast cancer ] [ Designated as safety issue: No ]we will compare LVEF (LVEF 1) measured before treatment with adjuvant Trastuzumab and concomitant Radiotherapy of breast/thoracic wall with LVEF (LVEF 2) measured at follow up (after adjuvant treatment) outpatient examination. We will then compare the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for left breast cancer with the difference in LVEF (LVEF 2-LVEF 1) measured in patients treated for right breast cancer
- occurrence of cardiovascular events over time in both groups (RT for left/right breast) [ Time Frame: from 6 months to five years after adjuvant therapy with trastuzumab ] [ Designated as safety issue: No ]occurrence of cardiovascular events over time in both groups (irradiated left / right breast) will be showed by the method of Kaplan-Meier. Groups will be compared with the log rank test.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
The investigators know from the studies, that were already published, that for HER2 positive early breast cancer patients in adjuvant treatment concomitant radiotherapy and trastuzumab is safe during the treatment. But there is no study with long term results of cardial function, especially combination of Left ventricular ejection fraction (LVEF) and NT-proBNP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572883
|Institut of oncology Ljubljana|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Tanja Marinko, MD||Institute of Oncology Ljubljana|