E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
female breast cancer |
carcinoma della mammella |
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E.1.1.1 | Medical condition in easily understood language |
female breast cancer |
carcinoma della mammella |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006860 |
E.1.2 | Term | Ca breast |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007305 |
E.1.2 | Term | Carcinoma breast |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
to reduce breast cancer recurrence |
ridurre il rischio di recidive di carcinoma mammario |
|
E.2.2 | Secondary objectives of the trial |
To improve cardio-metabolic markers, quality of life and to study possible links beetwen lifestyle and epigenetic factors through microRNA analysis |
Migliorare i fattori cardio-metabolici e la qualit¿ di Vita delle pazienti, e di studiare i possibili legami tra fattori epigenetici e stile di vita tramite analisi di microRNA |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women with primary diagnosis of histologically confirmed breast cancer (stages I-III, Table 1), without metastasis, within 12 months from histological diagnosis. 2. Age = 30 and < 75 years. 3. Patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment. The consent form has to be obtained before any protocol procedure.
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1. Pazienti donne con prima diagnosi di CM istologicamente diagnosticato (stadi I-III, Tabella 1), senza metastasi, entro i 12 mesi precedenti. 2. Pazienti di età = 30 e < 75 anni. 3. Pazienti in grado di comprendere e disposti a firmare il modulo di consenso informato e capaci di aderire allo schema delle visite dello studio e agli altri requisiti del protocollo. Il consenso informato scritto deve essere ottenuto prima di qualsiasi procedura.
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E.4 | Principal exclusion criteria |
1. Patients who do not possess the inclusion criteria for this study. 2. Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL) 3. Patients with any previous or with current concomitant other malignant cancer 4. Patients with diagnosis of AIDS 5. Pregnant or lactating women 6. Patients with severe renal insufficiency 7. Patients with kidney stones (nephrocalcinnosis or nephrolithiasis) 8. Patients participating in other lifestyle clinical trials
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1. Pazienti che non possiedono i criteri d’inclusione sopra riportati. 2. Pazienti con sarcoidosi o altre malattie granulomatose o con ipercalcemia (Ca>11mg/dl) 3. Pazienti con precedenti o concomitanti patologie oncologiche maligne 4. Pazienti con diagnosi di AIDS 5. Pazienti in gravidanza o allattamento 6. Pazienti con grave insufficienza renale 7. Pazienti con calcolosi renale (nefrocarcinosi o nefrolitiasi). 8. Pazienti che partecipano ad altri studi clinici di lifestyle.
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E.5 End points |
E.5.1 | Primary end point(s) |
reduction of breast cancer recurrence |
Riduzione del rischio di recidive di carcinoma mammario |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 33 months |
fino a 33 mesi |
|
E.5.2 | Secondary end point(s) |
determination of cardiometabolic factors (glycemia, insulinemia, blood lipids, etc) ; modulation of serum microRNA |
valutazione dei fattori cardio-metabolici (glicemia, insulinemia, lipidi sierici, etc) ; modulazione di microRNA sierici |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
33 months;
33 months |
33 mesi; 33 mesi |
|
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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 |