Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institute of Oncology Ljubljana
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- difference in LVEF (Left Ventricular Ejection Fraction)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Recurrence of disease
Outcomes
Primary Outcomes
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 Outcomes
- occurrence of cardiovascular events over time in both groups (RT for left/right breast)(from 6 months to five years after adjuvant therapy with trastuzumab)