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Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging (MRTOX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Francois Baclesse
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01436604
First received: September 15, 2011
Last updated: July 3, 2014
Last verified: July 2014

September 15, 2011
July 3, 2014
February 2012
August 2015   (final data collection date for primary outcome measure)
Proportions of late enhancement in patients with LV dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

A cardiac MRI is considered positive if demonstrated a late hyperintense from 15 to 20 minutes after injection of gadolinium chelate, whatever its size, topography subepicardial (intramyocardial) and without vascular systematization.

The primary endpoint is the proportion of delayed enhancement in the LV dysfunction group and the control group.

Same as current
Complete list of historical versions of study NCT01436604 on ClinicalTrials.gov Archive Site
Proportion of patients recovering at 6 months in the absence of late enhancement signal in MRI heart after injection of gadolinium and compare the results of biological assays [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cancer, Breast
  • LV Dysfunction
Other: Cardiac MRI

The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.

After establishing a good quality ECG synchronization, the following sequences are carried out successively:

  • Sequences locating anatomical
  • T2 black blood (such as ESF)
  • rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex
  • T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.
  • LV dysfunction group
    Cardiac MRI
    Intervention: Other: Cardiac MRI
  • Control group
    Cardiac MRI
    Intervention: Other: Cardiac MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women over 18 years
  • Free and informed consent signed
  • Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic
  • LVEF> 50% angioscintigraphy before the start of treatment with Herceptin ®,
  • Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)
  • Patient receiving treatment with Herceptin ®,
  • Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,
  • For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.

Exclusion Criteria:

  • Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),
  • History of ischemic heart disease or myocarditis
  • Known allergy to trastuzumab, murine proteins or any of the excipients
  • Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)
  • Renal impairment (creatinine clearance <60 ml / min according to the MDRD formula)
  • Arrhythmia atrial fibrillation,
  • Contraindications to the administration of Dotarem ®,
  • Patient unable to give informed consent,
  • Adult Trust,
  • Pregnant or lactating
  • Patient unable to undergo a medical for geographical, social or psychological.
Female
18 Years and older
No
Contact: MANRIQUE Alain, Pr (+33) 2 31 47 02 87 manrique@cyceron.fr
Contact: SWITSERS Odile, Dr (+33) 2 31 45 50 02 o.switsers@baclesse.fr
France
 
NCT01436604
MRTOX
Yes
Centre Francois Baclesse
Centre Francois Baclesse
Not Provided
Study Chair: MANRIQUE Alain, Pr GIP Cyceron
Principal Investigator: SWITSERS Odile, Dr Centre François Baclesse
Centre Francois Baclesse
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP