Cardiac Toxicity in Medical Treatment of Breast Cancer

NCT ID: NCT02440620

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Heart Failure Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ann Banke

MD, Ph.d.-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob Moeller, MD, DMsc

Role: STUDY_DIRECTOR

Odense University Hospital

Locations

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Odense University Hospital

Odense C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20140090

Identifier Type: -

Identifier Source: org_study_id

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