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

Primary Purpose

Cancer, Breast, LV Dysfunction

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Cardiac MRI

About this trial

This is an interventional diagnostic trial for Cancer, Breast focused on measuring cardiac MRI, Cancer, Breast, Herceptin, LV dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Centre François Baclesse
Centre Georges-François Leclerc
Clinique du Bois
CHU de NANCY

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

LV dysfunction group

Control group

Arm Description

Cardiac MRI

Outcomes

Primary Outcome Measures

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.

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

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

Full Information

NCT ID

NCT01436604

First Posted

September 15, 2011

Last Updated

July 27, 2017

Sponsor

Centre Francois Baclesse

1. Study Identification

Unique Protocol Identification Number

NCT01436604

Brief Title

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

Acronym

MRTOX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Terminated

Why Stopped

lack of recruitment

Study Start Date

February 2012 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Francois Baclesse

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Breast, LV Dysfunction

Keywords

cardiac MRI, Cancer, Breast, Herceptin, LV dysfunction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LV dysfunction group

Arm Type

Other

Arm Description

Cardiac MRI

Arm Title

Control group

Arm Type

Other

Arm Description

Cardiac MRI

Intervention Type

Other

Intervention Name(s)

Cardiac MRI

Intervention Description

The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI. After establishing a good quality ECG synchronization, the following sequences are carried out successively: Sequences locating anatomical T2 black blood (such as ESF) rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage.

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MANRIQUE Alain, Pr

Organizational Affiliation

GIP Cyceron

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

SWITSERS Odile, Dr

Organizational Affiliation

Centre François Baclesse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre François Baclesse

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

Centre Georges-François Leclerc

City

Dijon

Country

France

Facility Name

Clinique du Bois

City

Lille

Country

France

Facility Name

CHU de NANCY

City

Nancy

ZIP/Postal Code

54511

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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