NCT01436604

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

September 15, 2011

Last Update Submit

July 27, 2017

Conditions

Cancer, BreastLV Dysfunction

Keywords

cardiac MRICancerBreastHerceptinLV dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (1)

  • 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

    2 years

Study Arms (2)

LV dysfunction group

OTHER

Cardiac MRI

Other: Cardiac MRI

Control group

OTHER

Cardiac MRI

Other: Cardiac MRI

Interventions

Cardiac MRIOTHER

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.

Control groupLV dysfunction group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ®,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre François Baclesse

Caen, 14076, France

Location

Centre Georges-François Leclerc

Dijon, France

Location

Clinique du Bois

Lille, France

Location

CHU de NANCY

Nancy, 54511, France

Location

MeSH Terms

Conditions

Breast NeoplasmsVentricular Dysfunction, LeftNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • MANRIQUE Alain, Pr

    GIP Cyceron

    STUDY CHAIR

  • SWITSERS Odile, Dr

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2011

First Posted

September 19, 2011

Study Start

February 1, 2012

Primary Completion

August 1, 2015

Study Completion

May 1, 2017

Last Updated

July 28, 2017

Record last verified: 2017-07

Locations

FR(4)