E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the early cardiac damage induced by Trastuzumab TDI technique in patients with metastatic breast HER-2 positive. - Analyze the correlation between the alterations observed instrumental to TDI, and changes in circulating levels of biochemical markers of cardiac damage and parameters of chronic inflammation and oxidative stress - |
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E.2.2 | Secondary objectives of the trial |
Evaluate the predictive significance of early cardiac damage found to TDI (demonstrating a correlation between heart damage and possible early onset of clinically significant cardiac damage in patients in follow-up) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent (approved by the Ethics Committee) is obtained before any procedure studiospecifica. - Age: 18-70 years - Ability to adhere to the procedures of the Protocol - Women with breast cancer, histologically or cytologically documented HER2-positive in the pre-or post-menopausal, with disease radically operated, loco-regional relapse with locally advanced disease, with metastatic disease who will receive Herceptin as provided the Summary of Product Characteristics.
- Performance status (PS), according to the Eastern Cooperative Oncology Group (ECOG): 0-2. - Value of LVEF> 55% - A previous radiation therapy is allowed if administered in the adjuvant setting as an integrated treatment of early stage breast cancer provided they did not result in heart damage documented by an assessment instrument. - Adequate bone marrow function (absolute neutrophil de = 1.5x109 / L, platelet count = 100x109 / L, hemoglobin = 9 g / dl) - Adequate liver function (total bilirubin <1.5volte the upper limit of normal (ULN, AST, ALT <2.5xULN) - Adequate renal function (serum creatinine = 1.25xULN) - Women not pregnant or lactating |
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E.4 | Principal exclusion criteria |
Diagnosis of pharmacologically uncontrolled arterial hypertension (systolic> 150mmHg and / or diastolic> 100mmHg). - Diabetes mellitus type 1-2 is not controlled pharmacologically (fasting blood glucose> 250mg/dl). - Uncontrolled Hypercholesterolemia (> 300mg/dl), uncontrolled hypertriglyceridemia (> 300mg/dl) - Patients carriers of a pacemaker or heart valve - Diagnosis of chronic atrial fibrillation or paroxysmal atrial fibrillation - Significant cardiovascular disease (active), such as acute cerebrovascular accident (6mesi prior to enrollment), myocardial infarction (6 months prior to enrollment), unstable angina, congestive heart failure (class II according to the NYHA). - Treatment with any investigational agent, or participation in another clinical trial in 28giorni preceding enrollment |
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E.5 End points |
E.5.1 | Primary end point(s) |
identify the changes of cardiac parameters (TDI)), in particular, and SR Strain, and laboratory abnormalities predictive of cardiac damage to TDI. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |