Non evidence of disease (NED) Breast cancer.
Conditions
Interventions
Trade Name: Caelyx®
Product Name: Caelyx®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorrubicina Liposomal Pegilada
Concentration unit: mg/ml milligram(s)/millil
Sponsors
Dr. Llombart Cussac
Eligibility
Sex/Gender
All
Inclusion criteria
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 & 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Determinate the free and the global disease survival. ;Main Objective: 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.;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 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. | — |
Countries
Spain
Outcome results
None listed