Clinical trial · Observational
Assessment of Cardiotoxicity After Chemotherapy for Breast Cancer by Cardio-vascular Magnetic Resonance (MR)
Characterization of the Cardiotoxic Effects of Chemotherapies With Anthracyclines and Trastuzumab for Breast Cancer by Contrast-enhanced Cardiovascular Magnetic Resonance Imaging (CMR).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No subjects indentifiable
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardio-vascular MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- I
- description
- Consecutive patients with first-time diagnosis of metastatic breast cancer undergoing chemotherapy with anthracyclines and/or trastuzumab.
- interventionNames
- Other: Cardio-vascular MRI
Primary outcomes (1)
- measure
- Drop in ejection fraction of 10% as compared to baseline
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDNathan DM. Rosiglitazone and cardiotoxicity--weighing the evidence. N Engl J Med. 2007 Jul 5;357(1):64-6. doi: 10.1056/NEJMe078117. Epub 2007 Jun 5. No abstract available. PMID 17551161
- BACKGROUNDMcArthur HL, Chia S. Cardiotoxicity of trastuzumab in clinical practice. N Engl J Med. 2007 Jul 5;357(1):94-5. doi: 10.1056/NEJMc070065. No abstract available. PMID 17611218
- BACKGROUNDWassmuth R, Lentzsch S, Erdbruegger U, Schulz-Menger J, Doerken B, Dietz R, Friedrich MG. Subclinical cardiotoxic effects of anthracyclines as assessed by magnetic resonance imaging-a pilot study. Am Heart J. 2001 Jun;141(6):1007-13. doi: 10.1067/mhj.2001.115436. PMID 11376317
- BACKGROUNDFriedrich MG, Strohm O, Schulz-Menger J, Marciniak H, Luft FC, Dietz R. Contrast media-enhanced magnetic resonance imaging visualizes myocardial changes in the course of viral myocarditis. Circulation. 1998 May 12;97(18):1802-9. doi: 10.1161/01.cir.97.18.1802. PMID 9603535