Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01436604
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01436604
Study Brief:
Protocol Section:
NCT01436604