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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572883
• Other study ID #: eHER2-TM
• Status: Completed
• Phase: N/A
• First received: April 4, 2012
• Last updated: October 15, 2014
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2014
• Source: Institute of Oncology Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Slovenia	Institut of oncology Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in LVEF (Left Ventricular Ejection Fraction)	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	from one to six years from adjuvant radiotherapy for early breast cancer	No
Secondary	occurrence of cardiovascular events over time in both groups (RT for left/right breast)	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.	from 6 months to five years after adjuvant therapy with trastuzumab	No