Cancer, BreastPhase 2MRTOXNCT01436604
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
A Phase 2 study testing Cardiac MRI in people with Cancer, Breast and LV Dysfunction, run by Centre Francois Baclesse at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Breast, LV Dysfunction
- What is being tested?
- Cardiac MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2012to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François Baclesse
Caen, 14076
Centre Georges-François Leclerc
Dijon
Clinique du Bois
Lille
CHU de NANCY
Nancy, 54511
About this study
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.
- Conditions
- Cancer, Breast, LV Dysfunction
- Being tested
- Cardiac MRI
- Keywords
- cardiac MRI, Cancer, Breast, Herceptin, LV dysfunction
- Medical subject headings
- Breast Neoplasms, Ventricular Dysfunction, Left, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| LV dysfunction group | Other | Cardiac MRI Receives: Other: Cardiac MRI |
| Control group | Other | Cardiac MRI Receives: Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionMay 2017
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MANRIQUE Alain, Pr, Study chair, GIP CyceronSWITSERS Odile, Dr, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436604
- Sponsor's protocol ID
- MRTOX
- Acronym
- MRTOX
- Status last verified
- Jul 2017
- First submitted
- 15 Sep 2011
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01436604
- Acronym / sponsor ID
- MRTOX / MRTOX
- Conditions
- Cancer, Breast, LV Dysfunction
- Keywords
- cardiac MRI, Cancer, Breast, Herceptin, LV dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LV dysfunction group | Other | Other: Cardiac MRICardiac MRI |
| Control group | Other | Other: Cardiac MRICardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIThe 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. | Other | Control group, LV dysfunction group |
Primary outcome
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.
Time frame: 2 years
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANRIQUE Alain, Pr study chair
GIP Cyceron
SWITSERS Odile, Dr principal investigator
Centre François Baclesse
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiac MRI in people with Cancer, Breast and LV Dysfunction, run by Centre Francois Baclesse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.