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

Centre Francois Baclesse

Status and phase: Terminated; Phase 2

Conditions: Cancer, Breast; LV Dysfunction

Treatments: Other: Cardiac MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01436604

MRTOX

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

LV dysfunction group

Other group

Description:

Cardiac MRI

Treatment:

Other: Cardiac MRI

Control group

Other group

Description:

Cardiac MRI

Treatment:

Other: Cardiac MRI