E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with metastatic breast cancer |
Pazienti con carcinoma della mammella metastatico |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with metastatic breast cancer |
Pazienti con tumore della mammella in fase metastatica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with MBC in relation to toxicities already described in clinical trials, and neurotoxicity in particular. |
Questo studio ha come obiettivo primario la valutazione della tollerabilità di Eribulina nelle pazienti non selezionate con tumore mammario metastatico. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial include:
•To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy
•To describe treatment efficacy in terms of duration of treatment and impact on survival.
|
Obiettivi secondari sono la valutazione della compliance al trattamento e l’efficacia dello stesso. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1.Female patients ≥18 years
2.Diagnosis of metastatic breast cancer
3.Previous treatment with anthracyclines and taxanes
4.Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication
5.Ability to comply with sample collection
6.Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
7.Absence of any contraindication to treatment as in sections “Contraindication” “Special warning” and “Interaction with other medicinal product” of the Summary of product characteristics (SPC).
|
−Donne con età > 18.
−Diagnosi di neoplasia mammaria metastatica
−Precedente trattamento con antracicline e taxani
−Pazienti che inizieranno un trattamento con Eribulina o che hanno ricevuto la prima dose (ciclo 1, giorno 1) di Eribulina, secondo le indicazioni da scheda tecnica e la schedula approvate in Italia.
−Volontà e capacità di ottenere i campioni previsti dallo studio.
−Firma dei moduli di consenso informato dello studio e di consenso specifico alle analisi farmacogenetiche.
−Assenza di controindicazioni al trattamento come indicato nelle sezioni “Controindicazioni”, “Avvertenze speciali” e “Interazioni con altri medicinali ed altre forme di interazione” riportati nel “Riassunto delle caratteristiche del prodotto”.
|
|
E.4 | Principal exclusion criteria |
The presence of any of the following will exclude a subject from study enrollment:
1.Previous treatment with Eribulin in a previous line of treatment
2.Previous treatment with Eribulin off label
|
−Pazienti pretrattate con Eribulina in precedenti linee di terapia.
−Pazienti in trattamento con Eribulina off-label.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1.Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade), especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropoenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.
|
1.Valutazione dell’incidenza, della severità e della durata di tutti gli eventi avversi (ogni grado) comparsi durante il trattamento con Eribulina, con particolare attenzione agli eventi più comuni riportati in studi clinici precedenti (astenia/fatigue, neutropenia, alopecia, nausea, neuropatia periferica e costipazione).
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the treatment untill 30 days after treatment discontinuation |
Durante il trattamento fino a 30 giorni dopo l'ultima somministrazione |
|
E.5.2 | Secondary end point(s) |
-Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy
-Evaluation of quality of life during treatment using EORTC QLQ-C30 and QLQ-BR23 questionnaires.
-Assessment of dose intensity and dose schedule maintenance.
-DOT (Duration Of Treatment) and OS (Overall Survival).
|
-Valutazione dell’associazione tra una serie di polimorfismi selezionati e la neuropatia periferica di qualsiasi grado, nelle pazienti che svilupperanno neurotossicità.
-Valutazione della qualità di vita del paziente durante il trattamento, mediante la compilazione da parte delle pazienti dei questionari EORTC QLQ-C30 e QLQ-BR23.
-Valutazione dell’intensità della dose e mantenimento della stessa.
-Valutazione del tempo di durata del trattamento (DOT) e della sopravvivenza globale (OS)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the treatment, untill 30 days after treatment discontinuation and untill death |
Durante il trattamento fino a 30 giorni dopo l'ultima somministrazione e fino al decesso |
|
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 | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 0 |
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 | 22 |
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 | No |
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
|
Last patient enrolled: approximately December 2015. Cycles with Eribulin mesylate will be repeted until progression of disease, unacceptable toxicity, patient refusal or medical decision. |
L'ultimo paziente verrà arruolato all'incirca a dicembre 2015. Il trattamento con Eribulina mesilatocontinuerà fino a progressione di malattia, tossicità inaccettabile, rifiuto del paziente o per decisione clinica. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |