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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier:
NCT01572883
First received: April 4, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Concomitant Radiotherapy and Trastuzumab on Cardiotoxicity of Patients Treated for Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:
  • difference in LVEF (Left Ventricular Ejection Fraction) [ Time Frame: from one to six years from adjuvant radiotherapy for early breast cancer ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572883

Locations
Slovenia
Institut of oncology Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
Investigators
Principal Investigator: Tanja Marinko, MD Institute of Oncology Ljubljana
  More Information

No publications provided

Responsible Party: Institute of Oncology Ljubljana
ClinicalTrials.gov Identifier: NCT01572883     History of Changes
Other Study ID Numbers: eHER2-TM
Study First Received: April 4, 2012
Last Updated: May 7, 2012
Health Authority: Slovenia: Ministry of Health

Keywords provided by Institute of Oncology Ljubljana:
adjuvant treatment with Radiotherapy and trastuzumab

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014