E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non evidence of disease (NED) Breast cancer. |
|
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 |
Analyze the cardiac safety profile of liposomal pegillated doxorrubicine in patients with Non evidence of disease(NED) breast cancer and previously treated with Antraciclines (240 to 360 mg/m2 of Doxorrubicine, or equivalent), observed at 3 months form completion therapy. |
|
E.2.2 | Secondary objectives of the trial |
Determinate the free and the global disease survival.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Before to begin the protocol specific process, it must obtain and document according to the local requirement, the patient written informed consent. 2. Patients with breast cancer histologicaly confirmed and with a complete surgical resection in 7 weeks at the latest, with any of the following process: - Local locoregional recurrence: Within the breast after conservative surgery or Within the chest after mastectomy or Ipsilateral lymph nodes (axillary’s and/or supraclavicular). - Contralateral breast recurrence (stage I to IIIa). - Metastatic monostotic lesion. - A primary early breast cancer (stage I to IIIa) if previously exposed to anthracyclins for other curable tumor; i.e., Hodgkin’s disease, NHL. 3. Previous exposition to anthracycline (doxorubicin doses of 240 to 360 mg/m2, or 360 to 600 mg/m2 for epirubicin), and more than 1 year from completion of prior chemotherapy. 4. Age: >18 & <75 years old. 5. ECOG<2 6. LVEF > 50% 7. Live expentancy > 12 weeks. 8. Women of childbearing age have to do an aproved anticonceptive method during the trial and the next 3 months. 9. Laboratoy Requirements: Right haematological, renal and hepatical function.
|
|
E.4 | Principal exclusion criteria |
1. Evidence of metastatic disease non manageable with surgery. 2. Presence of any other active primary tumor, except basal cells or escamous skin cells carcinoma, or 'in situ' carcinoma. 3. Expected therapy with Herceptin or any other drug with potential cardiac toxicity within three months from completion of Caelix therapy. 4. Any experimental drug in the 4 weeks prior to inclusion or within three months from completion of therapy. Taxanes and any hormonal therapy for breast cancer are allowed four weeks after the last course of Caelix. 5. Antecedents of cardiopathy class II or bigger than the 'New York Heart Association' with congestive cardiac desease. 6. Gestant patients or in lactancy period. 7. Patients with antecedents of alergic reactions to the drugs in trial. 8. Clinically significant hepatopathy. 9. Patients with non controlled infections. 10. Any circumstance that impede a correct monitoring. 11. Male patients. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients with cardiotoxicity defined as:
- Signs/symptoms of congestive cardiac insufficiency and disminution of LVEF > 10% versus basal and with an absolut value < lower normal limit. - Decrease of LVEF > 15% versus basal, independent of the absolut value. - Decrease of LVEF < 10% versus basal, with an absolut value < 45%.
Other: Time until response, time until progression and global survival.
|
|
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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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) | 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.8.3 |
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
|
When 4 cycles of treatment are completed, the patient will do an evaluation of the disease stage every 3 months until desease progression, death or monitoring lost.
|
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |