Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01572883
• Lead Sponsor: Institute of Oncology Ljubljana

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 175

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in LVEF (Left Ventricular Ejection Fraction)	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Institut of oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia