E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients wiyh metastatic breast cancer her2 negative first line treatment |
pazienti affette da carcinoma mammario metastatico Her2negativo in trattamento di I linea |
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E.1.1.1 | Medical condition in easily understood language |
breast metastatic cancer4 Her2 negative |
cancro alla mammella con metastasi Her2 negativo, in terapia di I linea |
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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 | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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 |
evaluate the performance in terms of response rates (RR) and quality of life |
valutare l'attività in termini di percentuali di risposte (RR) e di qualità di vita |
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E.2.2 | Secondary objectives of the trial |
evaluate time to progression (PFS) and overall survival (OS) |
valutare il tempo alla progressione (PFS)e la 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 |
LIFE QUALITY: Vers:N.1 Date:2012/03/07 Title:questionnaire FACT-B Objectives:quality of life
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QUALITA DELLA VITA: Vers:N.1 Data:2012/03/07 Titolo:QUESTIONARIO FACT-B Obiettivi:qualità di vita
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E.3 | Principal inclusion criteria |
• histologically proven breast carcinoma Her-2 negative • Age 18-75 years • State of validity (WHO) ≤ 2 • Disease stage IIIB / IV with the presence of at least one measurable lesion unidimensionalmente • Any previous adjuvant / neoadjuvant chemotherapy completed at least 1 year • Any previous adjuvant hormone therapy or in advanced disease with documented progression • Possible previous RT including not more than 30% of the skeleton containing bone marrow and terminated by at least 4 weeks • Adequate bone marrow function (GB 4.000/mm3 ≥, ≥ 2.000/mm3 neutrophils, platelets ≥ 100.000/mm3), hepatic (bilirubin ≤ 1.5mg%), renal (creatinine ≤ 1.2mg%) • Negative pregnancy test (urine or serum) made within 7 days prior to entry into the study in women of childbearing age, these patients should take effective non-hormonal contraception for the duration of treatment • The pre-manopausali patients with endocrine responsive disease can be treated with LH-RH analogue, the measurement of any ovarian activity with serum tests should be performed only once at baseline study. • Geographical Accessibility for follow-up • Written Informed Consent |
•carcinoma mammario istologicamente accertato Her-2 negativo •Età 18-75 anni •Stato di validità (WHO) ≤ 2 •Malattia in stadio IIIB/IV con presenza di almeno una lesione misurabile unidimensionalmente •Eventuale precedente chemioterapia adiuvante e/o neoadiuvante terminata da almeno 1 anno •Eventuale precedente ormonoterapia adiuvante o in malattia avanzata con progressione documentata •Eventuale precedente RT includente non oltre il 30% dello scheletro contenente midollo osseo e terminata da almeno 4 settimane •Adeguata funzionalità midollare (GB≥ 4.000/mm3, neutrofili ≥ 2.000/mm3; piastrine ≥ 100.000/mm3), epatica (bilirubina ≤ 1.5mg%), renale (creatininemia ≤1.2mg%) •Test di gravidanza negativo (urine o siero) effettuato nei 7 giorni precedenti l’entrata in studio nelle donne in età fertile; tali pazienti dovranno adottare efficaci misure contraccettive non ormonali per tutta la durata del trattamento •Le pazienti pre-manopausali con malattia endocrino responsiva possono essere trattate con LH-rh analogue, la misurazione con test sierici dell’eventuale attività ovarica va effettuata una sola volta al momento dell’arruolamento dello studio. •Accessibilità geografica per follow-up •Consenso Informato scritto |
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E.4 | Principal exclusion criteria |
• • Previous chemotherapy for metastatic disease or concomitant therapy with hormonal agents or biotherapy • Previous adjuvant / neoadjuvant chemotherapy with attainment of the maximum cumulative dose of Adriamycin of 450 mg / sqm and epirubicin of 900 mg / sqm. • symptomatic brain metastases • psychological disorders precluding the obtaining of informed consent • Other cancers (except basal or squamous cell skin cancers and carcinoma in situ of the cervix, if adequately treated) • LVEF <50% determined by echocardiogram or MUGA scan • Patients who are pregnant • uncontrolled arterial hypertension (systolic ≥ 150 mmHg and / or diastolic ≥ 100 mmHg) • Cardiovascular disease clinically active (eg acute myocardial infarction within 6 months prior to enrollment in this study, NYHA Class II CHF, severe cardiac arrhythmia, which may require medical treatment during the study and could interfere with the regularity of treatment, or is not controlled by medical treatment) • Leukocytes <4000/mmc, neutrophils <2000/mmc, platelets <100000/mmc • Impaired renal function (creatinine 1.25 times normal) or hepatic (GOT or GPT 1.25 times the normal values, unless the disease is not due to liver metastases) • Concomitant treatment with other experimental drugs |
•Precedente chemioterapia per malattia metastatica o concomitante terapia con agenti ormonali o bioterapie •Precedente chemioterapia adiuvante e/o neoadiuvante con raggiungimento del dosaggio cumulativo massimo consentito di Adriamicina pari a 450 mg/mq e Epirubicina pari a 900 mg/mq. •Metastasi cerebrali sintomatiche •Malattie psichiche precludenti l’ottenimento del consenso informato •Altre neoplasie ( ad eccezione del carcinoma cutaneo baso o spinocellulare e il carcinoma in situ della cervice, purché adeguatamente trattati) •LVEF<50% determinato con ecocardiogramma o MUGA scan •Pazienti in gravidanza •Ipertensione arteriosa incontrollata (sistolica ≥ 150 mmHg e/o diastolica ≥ 100 mmHg) •Malattia cardiovascolare clinicamente attiva (ad esempio un infarto acuto del miocardio nei 6 mesi precedente l’arruolamento in studio, CHF NYHA Classe II, aritmia cardiaca severa che possa richiedere un trattamento medico durante lo studio e possa interferire con la regolarità del trattamento stesso, o che non sia controllata dal trattamento medico) •Leucociti < 4000/mmc, neutrofili < 2000/mmc, piastrine < 100000/mmc •Alterazioni della funzione renale (Creatininemia 1.25 volte i valori normali) o epatica (GOT o GPT 1.25 volte i valori normali, a meno che la patologia non sia dovuto a metastasi epatiche) •Trattamento concomitante con altri farmaci sperimentali |
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluate the performance in terms of response rates (RR) and quality of life |
valutare l'attività in termini di percentuali di risposte (RR) e di qualità di vita |
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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) |
assess time to progression (PFS) and overall survival (OS) |
valutare il tempo alla progressione (PFS)e la sopravvivenza globale (OS) |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
activities in terms of responses, quality Add life, time to progression, overall survival |
attività in termini di risposte, qualitò di vita,tempo alla progressione, sopravvivenza globale |
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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 | 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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
- Stesso farmaco ad altro dosaggio |
- same IMP used at different dosage |
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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 | 19 |
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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The objective of this study is to verify if the weekly administration of Myocet and metronomic endoxan deserves validation in a larger series. |
l'obiettivo dello studio è quello di verificare se la somministrazione settimanale di myocet ed endoxan metronomico merita una validazione in una casistica più ampia. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |