Cardiac Toxicity in Medical Treatment of Breast Cancer

Breast Cancer Clinical Trial

— CaTOB  

Official title:

Cardiac Toxicity in Medical Treatment of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440620
• Other study ID #: S-20140090
• Status: Completed
• Start date: October 2014
• Est. completion date: August 2018

Study information

• Verified date: April 2019
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will describe the epidemiology including prognosis of heart failure related to treatment with anthracycline and trastuzumab for breast cancer.

In a prospective study Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer patients scheduled for trastuzumab treatment at Odense University Hospital, will be offered advanced echocardiographic examination, test of bio-markers and genetic markers for the purpose of investigating if early identification of patients in particular risk of developing heart failure is feasible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of HER2 positive breast cancer

• Adjuvant treatment with trastuzumab

Exclusion Criteria:

• Left ventricle ejection fraction (LVEF) <50%

• Chronic or persistent atrial fibrillation

• History of moderate or severe valvular heart disease.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity
• Heart Failure

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense c

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global longitudinal strain by two dimentional speckle tracking.		Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
Primary	Ratio between the mitral E velocity and early diastolic maximum global strain rate (E/SRE).		Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.