Cardiac Toxicity in Medical Treatment of Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02440620

Acronym

CaTOB

Enrollment

Registered

2015-05-12

Start date

2014-10-31

Completion date

2018-08-31

Last updated

2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Heart Failure

Keywords

Heart failure related to medical treatment of breast cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

Denmark

Outcome results