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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.
Verified February 2013 by Centre Francois Baclesse
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01436604
First received: September 15, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer, Breast
LV Dysfunction
 Other: Cardiac MRI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging

Resource links provided by NLM:

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

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LV dysfunction group
Cardiac MRI
 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.
Control group
Cardiac MRI
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436604

Contacts
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

Locations
France
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: ALLOUACHE Djelila, MD     (+33) 2 31 45 50 02     d.allouache@baclesse.fr    
Sub-Investigator: LEVY Christelle, MD            
Principal Investigator: ALLOUACHE Djelila, MD            
Sub-Investigator: DELCAMBRE Corinne, MD            
Sub-Investigator: BERTHET Pascaline, MD            
Sub-Investigator: GEFFRELOT Julien, MD            
Sub-Investigator: NOAL Sabine, MD            
Sub-Investigator: RIVIERE Alain, MD            
Sub-Investigator: HRAB Ioana, MD            
Centre Henri Becquerel Not yet recruiting
Caen, France, 76038
Contact: VEYRET Corinne, Dr     (+33) 2 32 08 22 30     cveyret@rouen.fnclcc.fr    
Principal Investigator: VEYRET Corinne, Dr            
Clinique du Bois Active, not recruiting
Lille, France
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Study Chair: MANRIQUE Alain, Pr GIP Cyceron
Principal Investigator: SWITSERS Odile, Dr Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01436604     History of Changes
Other Study ID Numbers: MRTOX
Study First Received: September 15, 2011
Last Updated: February 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
cardiac MRI
Cancer
Breast
Herceptin
LV dysfunction

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013