| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Locally advanced or Metastatic Breast cancer | | Cancro alla mammella metastatico o localmente avanzato | |
| 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 | 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) | |
| 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 compare the efficacy of E7389 versus capecitabine monotherapy, in terms of Overall Survival and Progression-Free Survival in patients with locally advanced or metastatic breast cancer. | | L'obiettivo primario dello studio e' confrontare l'efficacia di E7389 rispetto alla capecitabina in monoterapia, in termini di sopravvivenza globale e sopravvivenza senza progressione in pazienti con carcinoma mammario localmente avanzato o metastatico. | |
| E.2.2 | Secondary objectives of the trial | | To assess and compare between the two treatment groups: -Quality of Life measured using the EORTC questionnaire -Objective Tumor response Rate as measured using RECIST criteria -Duration of response -One, Two and Three year Survival -Tumor related Symptom Assessment measured by pain intensity (VAS)and analgesic consumption -safety Parameters (adverse events, laboratory parameters, concomitant medication, and study drug exposure. To investigate pharmacokinetic/pharmacodynamic relationship in a population pharmacokinetic study in a minimum of 200 patients in the E7389 arm. | | Gli obiettivi secondari sono valutare: La qualita` della vita misurata mediante il questionario EORTC Il tasso oggettivo di risposta tumorale misurato mediante i criteri RECIST La durata della risposta La sopravvivenza a uno,due e tre anni La valutazione dei sintomi correlati al tumore misurata mediante l'intensita` del dolore (VAS) e il consumo di analgesici I parametri di sicurezza (eventi avversi,parametri di laboratorio,farmaci concomitanti ed esposizione al farmaco in studio) Correlazioni farmacocinetiche/farmacodinamiche in una popolazione per l'analisi farmacocinetica comprendente un minimo di 200 pazienti nel braccio trattato con E7389 | |
| 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 | PHARMACOKINETIC/PHARMACODYNAMIC:
Vers:
Date:
Title:
Objectives:
| FARMACOCINETICA/FARMACODINAMICA:
Vers:
Data:
Titolo:Farmacocinetica in 200 pazienti nel braccio con E7389
Obiettivi:
| |
| E.3 | Principal inclusion criteria | | -Female patients with histologically or cytologically confirmed carcinoma of the breast -Patients with locally advanced or metastatic disease who have received up to three prior chemotherapy regimes, and no more than two prior regimes for advanced oand/or metastatic disease -regimens must have included an anthracycline and a taxane either in combination or in separate regimens - patient must have progressed during or affter theri last anti-cancer therapy and this must be documented -Patients with known HER2/neu over-expressing must additionally have been treated with trastuzumab -Patients with known estrogen receptor-expressing tumors must additionally have been treated with hormonal therapy -Age >= 18 years -Life expectancy of >= 3 months -Adequate renal function -Adequate bone marrow function - ECOG Performance Status of 0,1 or 2 | | -Pazienti femmine con carcinoma alla mammella confermato istologicamente o citologicamente -Pazienti con patologia metastatica o localmente avanzata che abbiano ricevuto fino a tre regimi chemioterapici precedenti e non piu` di due regimi precedenti per la malattia avanzata. I regimi devono aver contentuo un`antraciclina e un taxano in combinazione o in regimi separati - le pazienti devono aver avuto una progressione documentata durante l`ultima terapia anti-cancro -Pazienti con tumori esprimenti HER2/neu devono essere state trattate con trastuzumab -Pazienti con tumori esprimenti recettori estrogenici devono aver ricevuto un trattamento ormonale -Eta` >=18 anni -Aspettativa di vita >= 3 mesi -Adeguata funzionalita` renale -Adeguata funzionalita` del midollo osseo - ECOG performance status pari a 0,1 o 2 | |
| E.4 | Principal exclusion criteria | | -Patients who have received more than two prior chemotherapy regimens (other therapies are allowed e.g. anti-estrogens, trastuzumb and radiotherapy) -Patients who have received capecitabine as a prior therapy -Patients who have received chemotherapy, radiation, hormonal therapy or trastuzumab within three weeks of E7389 treatment start -Radiation therapy encompassing > 30% of marrow -Prior high dose chemotherapy with hematopoietic stem cell rescue -Prior treatment with mitomycin C or nitrosourea -Pulmonary lymphangitic including the use of oxigen -Patients with brain or subdural metastases -Patients with meningeal carcinomatosis Patients who are receiving anti-coagulant therapy -Women who are pregnant or breast- feeding | | -Pazienti che hanno ricevuto piu` di due regimi chemioterapici (altre terapie sono permesse es. anti-estrogeni, trastuzumb e radioterapia) -Pazienti che hanno ricevuto capecitabina come terapia precedente -Pazienti che hanno ricevuto chemioterapia, radiazione, terapia ormonale o trastuzumab entro tre settimane dall`inizio del trattamento con E7389 -Terapia con radiazioni che ha compreso >30% del midollo Precedente chemioterapia ad alte dosi con celleule staminali emopoietiche -Precedente trattamento con mitomicina C o nitrosourea -Coinvolgimento linfalgitico polmonare risultante in disfunzione polmonare che richiede trattamento attivo con ossigeno -Pazienti con metastasi subdurali o cerebrali -Pazienti con carcinomatosi meningeale -Pazienti che stanno ricevendo terapia anticoagulante -Donne in gravidanza o allattamento - | |
| E.5 End points |
| E.5.1 | Primary end point(s) | | Overall Survival is measured from the date of randomization until date of death from any cause or the last date the patient was known to be alive. Progression-Free Survival is measured from the date of randomization to the date of recorded progression of the disease or the death of the patient from any cause | | La sopravvivenza globale e' misurata dalla data di randomizzazione fino alla data di morte per qualsiasi causa o all'ultima data in cui si sapeva che il paziente era vivo. La sopravvivenza senza progressione e' misurata dalla data di randomizzazione alla data registrata di progressione o alla morte del paziente per qualsiasi causa | |
| 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 | Yes |
| 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 | 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 | 11 |
| 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 | Information not present in EudraCT |
| 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 | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 4 |
| 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 | 4 |
| 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 |
