E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
METASTATIC BREAST CANCER (MBC) |
CARCINOMA MAMMARIO METASTATICO |
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E.1.1.1 | Medical condition in easily understood language |
METASTATIC BREAST CANCER (MBC) |
CARCINOMA MAMMARIO METASTATICO |
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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 | 10055113 |
E.1.2 | Term | Breast cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Objective response rate |
Tasso di risposte obiettive |
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E.2.2 | Secondary objectives of the trial |
Toxicity QoL Progression Free Survival Overall Survival
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Tossicità Valutazione della Qualità di Vita Sopravvivenza libera da progressione (PFS) Sopravvivenza globale (OS)
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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 |
Other types of substudies Specify title, date and version of each substudy with relative objectives: TRANSLATE - TRANSLATIONAL v. 1.0 08feb2016
Objectives
Analysis of changes of major circulating immunologic factors during the TRANSLATE study.
Analysis impact of the observed changes (if any) on the patients’ outcome.
Analysis of immunologic status at progression.
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: TRANSLATE - TRANSLATIONAL v. 1.0 del 08/02/2016
Obiettivi
Analizzare le variazioni fra i maggiori fattori immunologici circolanti durante lo studio TRANSLATE.
Analizzare l’impatto dei cambiamenti osservati (se presenti) sull’outcome del paziente.
Analizzare lo stato immunitario alla progressione di malattia.
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E.3 | Principal inclusion criteria |
Hystologically confirmed MBC Metastatic disease previously treated with at least two or three lines of systemic therapy or progressed during or within three months from the last chemotherapy regimen Measurable disease (RECIST criteria version 1.1). At least one metastatic site suitable for irradiation. Signed informed consent. Geographical accessibility. Age = 18 y.o. Karnofsky P.S. = 60 Life expectancy > 3 months. Adequate bone marrow function (Absolut Neutrophil count ¿ =¿1,5 x 109/l, platelets ¿ =¿100 x 109/l, hemoglobin ¿ =¿10 g/dL). Adequate liver function: transaminases = 2.5 x upper limit of normality (ULN); bilirubin = 1.5 x ULN. Adequate renal function: Creatinine = ULN or creatinine clearance > 60 mL/min (Cockroft-Gault). Adequate contraception for childbearing potential women. Adequate cardiac function (LVEF ¿ 50% evaluated by MUGA Scan or Echocardiography and electrocardiogram)
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Carcinoma mammario metastatico confermato istologicamente Malattia metastatica pretrattata con almeno 2-3 linee di chemioterapia e progredita durante o entro 3 mesi dopo la fine dell'ultima chemioterapia Malattia misurabile secondo i criteri RECIST (versione 1.1) Almeno una sede di malattia suscettibile di trattamento radioterapico Consenso informato scritto firmato Accessibilità geografica Età maggiore od uguale a 18 anni Karnofsky Performance Status = 60% Aspettativa di vita > 3 mesi Adeguato profilo ematologico: conta assoluta dei neutrofili (ANC) = 1,5 x 109/l, piastrine = 100 x 109/l, emoglobina = 10 g/dL. Adeguata funzionalità epatica: transaminasi = 2,5 volte il limite superiore di normalità (ULN), bilirubina totale=1,5 volte ULN Adeguata funzionalità renale: creatinina sierica = ULN o clearance della creatinina calcolata (Cockroft-Gault) > 60 mL/min Adeguata contraccezione (le donne in età fertile devono usare un metodo contraccettivo non ormonale clinicamente accettato) Adeguata funzionalità cardiaca (frazione di eiezione > 50 %, valutata con MUGA scan o ecocardiogramma ed ECG) |
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E.4 | Principal exclusion criteria |
Prior malignancies Prior organ transplantation Brain metastasis Autoimmune or allergic disorders Previous HBV and/or HCV infections Previous IL-2 treatment Active steroid therapy Any active infection requiring specific treatment (Antibiotics, antimicotic, antiviral) Radiotherapy within 6 weeks before enrollment. Pregnant or lactating females. Other non-malignant uncontrolled systemic diseases or social conditions that would preclude trial entry in the opinion of the investigator.
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Pregresse neoplasie maligne d'altra origine nei precedenti 5 anni (esclusi tumori della cute non melanoma) Trapianto d'organo Metastasi cerebrali Patologia autoimmune od allergica Pregresse infezioni da HBV e/o HCV Pregresso trattamento con IL-2 Trattamento attivo con cortisonici Malattia infettiva in atto che necessiti di terapia specifica (antibiotica, antivirale o antimicotica) Radioterapia nelle 6 settimane precedenti l’arruolamento Gravidanza in atto od allattamento Presenza di altra condizioni non oncologica non controllata o condizione sociale che precludano l’ingresso in studio a giudizio del clinico sperimentatore
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate |
Tasso di risposte obiettive |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during treatment |
durante il trattamento |
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E.5.2 | Secondary end point(s) |
Toxicity; QoL; Progression Free Survival; Overall Survival |
Tossicità; Valutazione della Qualità di Vita ; Sopravvivenza libera da progressione; Sopravvivenza globale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
DURING TREATMENT AND DURING 4 WEEKS AFTER END OF TREATMENT; EVERY CYCLE AND END OF TREATMENT; from study entry to first documented disease progression or death from any cause whichever occurred first; from study entry to death from any cause |
DURANTE IL TRATTAMENTO E NELLE 4 SETTIMANE SUCCESSIVE AL TERMINE DEL TRATTAMENTO; AD OGNI CICLO E A FINE TRATTAMENTO; dall’entrata in studio al primo riscontro di progressione di malattia o morte per qualsivoglia causa; dall’entrata in studio e la morte per qualunque causa |
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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 | 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.8.3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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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Death of all enrolled patients |
decesso di tutti i pazienti arruolati |
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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 | 36 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 36 |
E.8.9.2 | In all countries concerned by the trial days | 0 |