Clinical trial · Interventional
Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
NCT01436604CI-TRIAL-00028835MRTOXterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| LV Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- LV dysfunction group
- description
- Cardiac MRI
- interventionNames
- Other: Cardiac MRI
- type
- OTHER
- label
- Control group
- description
- Cardiac MRI
- interventionNames
- Other: Cardiac MRI
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.