Clinical trial NCT01436604: Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
Official title: Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer, Breast
LV Dysfunction
Keywords: cardiac MRI
Cancer
Breast
Herceptin
LV dysfunction
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lille
country: France
facility: Clinique du Bois
city: Nancy
country: France
facility: CHU de NANCY
Study officials:
affiliation: GIP Cyceron
name: MANRIQUE Alain, Pr
role: STUDY_CHAIR
affiliation: Centre François Baclesse
name: SWITSERS Odile, Dr
role: PRINCIPAL_INVESTIGATOR
References: