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

Phase 2

Terminated

• Conditions: Cancer, Breast; LV Dysfunction
• Interventions: Other: Cardiac MRI

• Registration Number: NCT01436604
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Study Start: 2012-02
• Primary Completion: 2015-08
• Study Completion: 2017-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Cardiac MRI	Cardiac MRI
LV dysfunction group	Cardiac MRI	Cardiac MRI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Centre François Baclesse; 🇫🇷 Caen, France

Clinique du Bois; 🇫🇷 Lille, France

CHU de NANCY; 🇫🇷 Nancy, France

Centre Georges-François Leclerc; 🇫🇷 Dijon, France