Status:
TERMINATED
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Cancer, Breast
LV Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01436604
Start Date
February 1 2012
End Date
May 1 2017
Last Update
July 28 2017
Active Locations (4)
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1
Centre François Baclesse
Caen, France, 14076
2
Centre Georges-François Leclerc
Dijon, France
3
Clinique du Bois
Lille, France
4
CHU de NANCY
Nancy, France, 54511