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

Sponsor

Centre Francois Baclesse (Other)

Overall Status

Terminated

CT.gov ID

NCT01436604

Collaborator

(none)

Enrollment

Locations

Arms

62.9

Duration (Months)

4.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cancer, Breast LV Dysfunction	Other: Cardiac MRI	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Other: Control group

Cardiac MRI

Other: Cardiac MRI

Outcome Measures

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. [2 years]
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 [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.