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

Cancer, Breast Clinical Trial

— MRTOX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01436604
• Other study ID #: MRTOX
• Status: Terminated
• Phase: Phase 2
• First received: September 15, 2011
• Last updated: July 27, 2017
• Start date: February 2012
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Cardiotoxicity
• LV Dysfunction

Intervention

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.

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Georges-François Leclerc	Dijon
France	Clinique du Bois	Lille
France	CHU de NANCY	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	2 years
Secondary	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