Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
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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.
Condition or disease
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.
difference in LVEF (Left Ventricular Ejection Fraction) [ Time Frame: from one to six years from adjuvant radiotherapy for early breast cancer ]
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
Secondary Outcome Measures :
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 ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
breast cancer patients treated in Institut of Oncology Ljubljana,slovenia since year 2005.
Early breast cancer patients,treated adjuvantly with radiotherapy of the operated breast or thoracic wall and treated concomitantly with trastuzumab.
Reviewed many months after treatment, without recurrence of disease.