Cardiac Toxicity in Medical Treatment of Breast Cancer

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.

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Key information

Conditions

Heart Failure Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Heart Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital

Odense C, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Global longitudinal strain by two dimentional speckle tracking.

Time frame: 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).

Time frame: Change in outcome from initiation of trastuzumab treatment and after 3,6, and 9 month.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

University of Southern Denmark

Registry information

Acronym: CaTOB

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: May 12, 2015
Registry last updated: May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed