E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 |
To evaluate the safety of the combination as first line treatment, throught the cardiotoxicity rate (LVEF) in patients with advanced breast cancer, previously treated with anthracyclines as adjuvance. |
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E.2.2 | Secondary objectives of the trial |
Overall Response Rate Free Progression Survival, Tolerability, Time to treatment failure, Safety. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Written informed consent prior any specific protocol procedures. 2. Patients with advance breast cancer, histologically and citologically confirmed, mesurable illnesss according to RECIST criteria, do not irradiate previously 3. Women age >18 years. 4. ECOG performance status < 2 5. Patients must have been treated with previous adyuvant chemoterapy, for at least 12 months. 6. Previous adyuvant treatment must be anthracyclines, not administrated in combination with taxanes. Maximum total dose: 300 mg/m2 of doxorrubicin or 450 mg/m2 of epirrubicin. 7. Life expectancy > 6 months. 8. Normal cardiac function, LVEF (≥ 50%) with MUGA scanner or echocardiography. 9. Neutrophils ≥2.0x109/L, platelets ≥100x109/L, Hemoglobin ≥10g/dL. 10. Creatinine < 1 LSN or creatinine clearance ≥60mL/min 11. Bilirubin <1 LSN, AST/GOT <2.5 LSN, ALT/GPT <2,5 LSN and alkaline phosphatase <2.5 LSN 12. Women on childbearing potential must accept to use an effective method to avoid pregnancy (except hormonal treatment) during study and for the following 3 months. It will be mandatory a pregnancy test in the 14 days before the beginning ot the trial. 13. Complet extension study will be done, included thoraco-abdomino-pelvic CT. If there is a suspect of osseous illness, will be done a gammagraphy, and if the disease is confirmed, it will carry out a x-ray study. 14. Patients must follow-up all the study procedures and they will be available durint the development of the trial. |
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E.4 | Principal exclusion criteria |
1. Previous or concomitant chemotherapy treatment for metastasic breast cancer. 2. Previous treatment with taxans 3. Pregnant or nursing women. 4. Leptomeníngeous infiltration or del central system nervous. 5. Neuropathy ≥G2 (NCI-CTCAE). 6. Secondary cardiovascular pathology. 7. Previous LVEF<50% or miocardical infarction. 8. Neurology or psychiatry alteration that interfers the understanding of the request of the study or the informed consent. 9. Acute or chronic active infection. 10. Activ peptic ulcer or uncontrolled diabetes mellitus. 11. Another concomitant neoplasia, except basal cell carcinoma of skin or cervix carcinoma at least 5 years befote the present trial. 12. Patients with hypersensibility to anthracyclines or ovoderivados. Patients with hypersensibility to Docetaxel. Intoleranc to excipients. 13. Another medical treatment which interferes in the study or with the drug action or confuse the study results. 14. Chronic use of corticoids, except Stara 6 months before the present trial and low dose (< 20 mg of Metilprednisolona or equivalent). 15. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 4 weeks prior to study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective cardiotoxicity rate (LVEF). |
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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 | 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 | Information not present in EudraCT |
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 | 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) | 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.8.5 | 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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |