Cardiac Toxicity in Medical Treatment of Breast Cancer (CaTOB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02440620
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : April 6, 2017
University of Southern Denmark
Information provided by (Responsible Party):
Ann Banke, 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.

Condition or disease
Heart Failure Breast Cancer

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Toxicity in Medical Treatment of Breast Cancer
Study Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. ]
  2. 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. ]

Biospecimen Retention:   Samples With DNA
Blood samples will be analyzed for N-terminal proBNP and ultra-sensitive TnT. Targeted sequencing of a limited number of well-known genes related to heart failure will be conducted and analysis of potential future biomarkers related to heart failure is possible from blood samples stored in a biobank.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with HER2 positive breast cancer in adjuvant treatment with trastuzumab.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02440620

Contact: Ann Banke, MD +45 26278303

Odense University Hospital Recruiting
Odense c, Denmark, 5000
Contact: Ann Banke   
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Study Director: Jacob Moeller, MD, DMsc Odense University Hospital

Responsible Party: Ann Banke, MD, Ph.d.-student, Odense University Hospital Identifier: NCT02440620     History of Changes
Other Study ID Numbers: S-20140090
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Keywords provided by Ann Banke, Odense University Hospital:
Heart failure related to medical treatment of breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Heart Failure
Neoplasms by Site
Breast Diseases
Skin Diseases
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries