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Assessment of Cardiotoxicity After Chemotherapy for Breast Cancer by Cardio-vascular Magnetic Resonance (MR)

This study has been terminated.
(No subjects indentifiable)
Sponsor:
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
ClinicalTrials.gov Identifier:
NCT00679874
First received: May 15, 2008
Last updated: October 2, 2011
Last verified: October 2011
History of Changes
  Purpose

Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom Baker Cancer Centre (TBCC) and included into the study, if they are going to receive chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for the CMR study. Besides the usual clinical care for these patients (e.g. blood samples before each cycle of chemotherapy; MUGA scans to follow cardiac size and function), the patients will undergo serial contrast-enhanced CMR studies (before, during and 9-12 months after completion of the chemotherapy); patients will be seen at an outpatient clinic in the Dept. of Cardiac Sciences / Heart Function Clinic for a clinical assessment (including ECG, additional blood test like Troponin-T, BNP, 6-minute-walk-test) and recommendations will be made to medical treatment in patients with evidence for heart failure.

Time points for the CMR and clinic assessments will be co-coordinated with regularly scheduled test by the TBCC to avoid unnecessary burden for the patients. The oncologists at the TBCC will be blinded to the results of the CMR studies and to laboratory results, unless the participating cardiologists identify a clinical need for communication.

Standardized CMR protocols will be employed and all interpretations will be blinded to the time course of the chemotherapy and cardiotoxic side effects.

We will test the hypothesis, whether CMR can be useful in patients with potentially cardiotoxic chemotherapy to:

  • Identify patients at risk for the development of grade 2-4 cardiotoxic side effects as classified by the NCI guidelines (common toxicity criteria, 2001, 1-12)
  • Identify imaging parameters to predict early or late Cardiotoxicity
  • Provide additional clinical information to optimize medical treatment for heart failure

Condition Intervention
Breast Cancer
 Other: Cardio-vascular MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Cardiotoxic Effects of Chemotherapies With Anthracyclines and Trastuzumab for Breast Cancer by Contrast-enhanced Cardiovascular Magnetic Resonance Imaging (CMR).

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Drop in ejection fraction of 10% as compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
Consecutive patients with first-time diagnosis of metastatic breast cancer undergoing chemotherapy with anthracyclines and/or trastuzumab.
 Other: Cardio-vascular MRI
Contrast enhanced CMR studies at baseline, in the middle of chemotherapy and as follow-up

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consecutive patients with a first diagnosis of breast cancer will be identified at the Tom Baker Cancer Centre (TBCC) and included into the study, if they are going to receive chemotherapy with anthracyclines and / or Trastuzumab and do not have contra-indications for the CMR study.

Criteria

Inclusion Criteria:

  • First-time diagnosis of breast cancer
  • Planned chemotherapy with anthracyclines and / or Trastuzumab
  • Ability to give informed consent

Exclusion Criteria:

  • Contra-indications for CMR study (e.g. implanted pacemaker / ICD; severe renal impairment (GFR< 35 ml/min); severe claustrophobia)
  • Previous history of non-ischemic cardiomyopathies or myocardial inflammation
  • Inability to give informed consent
  • Concomitant drug abuse (e.g. cocaine)
  • Expected life expectancy < 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679874

Locations
Canada, Alberta
University of Calgary, Dept. of Cardiac Sciences and Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Oliver Strohm, MD, FESC University of Calgary
  More Information

Publications:

Responsible Party: Oliver Strohm, adunct Research Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00679874     History of Changes
Other Study ID Numbers: Cardiotox_001
Study First Received: May 15, 2008
Last Updated: October 2, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
Cardiovascular Magnetic Resonance Imaging
Cardiotoxicity
Anthracyclines
 Trastuzumab
Breast cancer
Toxicity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013