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


N/A
18 Years
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

difference in LVEF (Left Ventricular Ejection Fraction)

Outcome Description:

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

Outcome Time Frame:

from one to six years from adjuvant radiotherapy for early breast cancer

Safety Issue:

No

Principal Investigator

Tanja Marinko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Oncology Ljubljana

Authority:

Slovenia: Ministry of Health

Study ID:

eHER2-TM

NCT ID:

NCT01572883

Start Date:

December 2011

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • adjuvant treatment with Radiotherapy and trastuzumab
  • Breast Neoplasms

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