Cardiac Toxicity in Medical Treatment of Breast Cancer

Completed

• Conditions: Heart Failure; Breast Cancer

• Registration Number: NCT02440620
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis of HER2 positive breast cancer
• Adjuvant treatment with trastuzumab

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Exclusion Criteria

• Left ventricle ejection fraction (LVEF) <50%
• Chronic or persistent atrial fibrillation
• History of moderate or severe valvular heart disease.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global longitudinal strain by two dimentional speckle tracking.	Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.
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.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense c, Denmark