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

Phase 2
18 Years
Open (Enrolling)
Cancer, Breast, LV Dysfunction

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Chair

Investigator Affiliation:

GIP Cyceron


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

February 2012

Completion Date:

August 2014

Related Keywords:

  • Cancer, Breast
  • LV Dysfunction
  • cardiac MRI
  • Cancer
  • Breast
  • Herceptin
  • LV dysfunction
  • Breast Neoplasms
  • Carcinoma