E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Female, non metastatic histologically confirmed primary invasive breast cancer scheduled to receive neoadjuvant or adjuvant anthracyclines with or without anti Her 2 therapy, LVEF >50% |
Donne con carcinoma mammario invasivo non metastatico da sottoporre a chemioterapia adiuvante o neoadiuvante con o senza agenti anti Her2, LVEF>50%
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E.1.1.1 | Medical condition in easily understood language |
Patients with breast carcinoma scheduled to receive pre or postoperative chemotherapy, with normal heart function |
Pazienti con carcinoma mammario da sottoporre a chemioterapia pre o postoperatoria, con normale funzionalità cardiaca |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008444 |
E.1.2 | Term | Chemotherapy cardiotoxicity attenuation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Evaluation of reduction of both systolic and diastolic, early and late subclinical cardiotoxicity measured with traditional echocardiography and pulsed tissue doppler in pharmacologically treated patients compared to the placebo group |
Valutazione della riduzione del danno cardiovascolare subclinico sistolico e diastolico, precoce e tardivo, misurato con ecocardiografia tradizionale e Tissue doppler pulsato in pazienti trattate farmacologicamente, confrontate con il gruppo placebo |
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E.2.2 | Secondary objectives of the trial |
Evaluation of the reduction of symptomatic heart failure incidence in pharmacologically treated women compared to the placebo group. Evaluation of predictive value of some myocardial toxicity biomarkers. |
Valutazione della riduzione dell’incidenza di scompenso cardiaco sintomatico in pazienti trattate farmacologicamente confrontate con il gruppo placebo. Valutazione del valore predittivo di alcuni biomarkers di cardiotossicità. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female Age>18 Non metastatic Histologically confirmed primary breast cancer Scheduled to receive neoadjuvant or adjuvant chemotherapy with or without anti Her 2 therapy LVEF 50% |
Donne >18 anni Carcinoma della mammella non metastatico Da sottoporre a chemioterapia adiuvante o neoadiuvante con o senza agenti anti Her2 FE>50% |
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E.4 | Principal exclusion criteria |
Pregnant or lactating women Treatment with ACE inhibitors or beta blockers at diagnosis History of Grade >2 symptimatic congestive heart failure, previous myocardial infarction, significative symptoms relating to LVEF disfunction, valvular disfunction, cardiac arrythmias > G3 |
Donne incinta o in allattamento Trattamento con ACE inibitori o Beta bloccanti alla diagnosi Storia di scompenso cardiaco congestizio sintomatico maggiore di Grado 2, pregresso infarto miocardico, sintomi significativi relativi a disfunzione della funzionalità cardiaca,Disfunzione valvolare, aritmie cardiache> G3 |
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluation of subclinical cardiac damage, measured with conventional echography, pulsed tissue Doppler and 2D speckle tracking in treated patients compared to the placebo arm |
Valutazione della riduzione del danno cardiovascolare subclinico sistolico e diastolico, precoce e tardivo, misurato con ecocardiografia tradizionale, 2D speckle tracking e Tissue doppler pulsato in pazienti trattate farmacologicamente, confrontate con il gruppo placebo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Endpoint: evaluation of the reduction of incidence of symptomatic heart failure and of predictive value of some cardiotoxicity biomarker |
valutazione della riduzione dello scompenso cardiaco sintomatico e del valore predittivo di alcuni biomarker di cardiotossicità |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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 | 5 |
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 | 5 |
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 |