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

NCT01572883 | Completed

• 1 other identifier: eHER2-TM
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

adjuvant treatment with Radiotherapy and trastuzumab

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

breast cancer patients treated in Institut of Oncology Ljubljana,slovenia since year 2005.

You may qualify if:

• 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.

You may not qualify if:

• Recurrence of disease

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institut of oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tanja Marinko, MD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: April 6, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

SL (1)