E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally recurrent or metastatic triple negative breast cancer. |
Pazienti con tumore della mammella triplo negativo con recidiva locale o metastatico. |
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E.1.1.1 | Medical condition in easily understood language |
Advanced breast cancer. |
Tumore della mammella in stadio avanzato. |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006197 |
E.1.2 | Term | Breast cancer NOS stage IV |
E.1.2 | System Organ Class | 100000004864 |
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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 |
Attività della combinazione eribulina più gemcitabina. |
Activity of the combination eribulin plus gemcitabine |
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E.2.2 | Secondary objectives of the trial |
Fattibilità, sicurezza. |
Feasibility, safety. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PHARMACOGENETIC: Vers:1 Date:2012/08/20 Title:Prediction of Eribulin/Gemcitabine Toxicity and Activity in Patients with Metastatic Triple Negative Breast Cancer by Pharmacogenetic Profiling. Ancillary biologic study to ERIGE protocol. Objectives:To assess the role of study polymorphisms in predicting activity and toxicity with the combination of eribulin plus gemcitabine in patients with TNBC.
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FARMACOGENETICA: Vers:1 Data:2012/08/20 Titolo:Utilizzo di un profilo farmacogenetico nel predire attività e tossicità della combinazione di eribulina e gemcitabina in una popolazione di pazienti affette da carcinoma mammario metastatico a fenotipo “triple negative”. Studio biologico ancillare al protocollo ERIGE. Obiettivi:Valutare il ruolo dei polimorfismi genetici in studio nel predire attività e tossicità di una terapia con eribulina e gemcitabina in pazienti affette da carcinoma mammario metastatico a fenotipo “triple negative”.
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E.3 | Principal inclusion criteria |
Patients must have locally recurrent or metastatic breast cancer. Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or, e.g. in HER2 2+ cases, fluorescent in situ hybridization (FISH) < ratio of 1.8. Cancer recurrent after previous neoadjuvant and/or adjuvant chemotherapy including an anthracycline and a taxane (unless one or both were clinically contraindicated). Measurable disease. Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years. Patients must have a life expectancy of > 12 weeks. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 50%). Adequate bone marrow reserve, liver and renal function. All patients must have given signed, informed consent prior to registration on study. |
Pazienti con carcinoma della mammella con recidiva locale o metastatico· Pazienti con recettori estrogenici negativi (ER-), recettori progestinici negativi (PR-), recettori per fattore di crescita epidermico 2-negativi (Her2-) (0, 1+) oppure, nei casi HER2 2+, con rapporto FISH (fluorescent in situ hybridization) < 1.8. Prima ripresa di malattia dopo una precedente chemioterapia neadiuvante e/o adiuvante con antracicline e taxani (eccetto quando uno o entrambi fossero stati clinicamente controindicati). Malattia misurabile. E’ammessa una precedente diagnosi di tumore se la paziente sia libera da malattia e abbia terminato il trattamento per la precedente neoplasia da almeno tre anni. Pazienti con aspettativa di vita> 12 settimane. Pazienti con Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 50%). Adeguata funzionalità midollare, epatica e renale. Tutte le pazienti devono aver firmato il consenso informato dello studio prima di essere inclusi nello studio |
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E.4 | Principal exclusion criteria |
Prior gemcitabine or eribulin. Any prior chemotherapy for metastatic disease. Patients with brain metastases |
Precedente trattamento con gemcitabina ed eribulina. Precedente chemioterapia per la malattia metastatica. Presenza di metastasi cerebrali |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate (ORR) of the combination of Eribulin plus Gemcitabine based on local investigator’s assessment according to RECIST v1.1. |
Tasso di risposte obiettive(ORR), valutato dall’investigatore locale secondo i criteri RECIST v 1.1, della combinazione di Eribulina più Gemcitabina. |
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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) |
Progression-free survival(PFS), duration of response (DOR), time to treatment failure (TTF) and overall survival (OS)of the combination Eribulin plus Gemcitabin. |
Sopravvivenza libera da progressione(PFS), durata della risposta (DOR), tempo al fallimento del trattamento (TTF) e sopravvivenza globale (OS) della combinazione di Eribulina più Gemcitabina. |
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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 | No |
E.6.3 | Therapy | Yes |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |