Patients with histologically or citologically confirmed advanced or metastatic breast cancer, no subject to curative local treatment.
Conditions
Interventions
Trade Name: Pr 1: Navelbine
Product Name: Vinorelbine
Product Code: PM259
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: vinorelbine
Current Sponsor code: PM259
Concen
Sponsors
GON-North Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or citologically confirmed advanced or metastatic breast cancer, no subject to curative local treatment. 2. Patients > 18 years of age 3. Subjects must have at least one measurable lesion according to RECIST criteria (Response Evaluation Criteria in solid Tumors) 4. Patient must be accessible for follow up and to have Karnofsky of 80%. 5. Patients who have received neo/ adjuvant chemotherapy (only one line of treatment) previously with a free disease period longer than 1 year. 6. Patients who have received neo/ adjuvant or advanced endocrine therapy 7. Patients with normal cardiac fraction measured by echocardiogram and (FEVI) =50%. 8. Life expectancy longer than 12 months. 9. Adequate Hematologic and hepatic function. 10. Patients potentially able to conceive children must take contraconceptive treatment during the clinical trial. 11. Patients with Signed informed consent. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women subject to conceive children without contraceptive treatment, pregnant or lactating female. 2. Patients previously treated with chemotherapy for advanced disease. 3. Patients with organ allografts. 4. Patients with significant and uncontrolled cardiac disease in the last one year. 5. Patients with no adequate renal, hepatic or respiratory function. 6. Patients with hypercalcemia (serum calcio > 11,5 mg/dl). 7. Patients with active or uncontrolled infection. 8. Patients without other malignancy or who has been disease-free for 5 years (excepting skin basal cels carcinoma and in situ cervix carcinoma) 9. Patients who need to take the following pharmaceutical products:Diethylstilbestrol; dicycomine; dorbanex/ canthaxanthin; Purtussi vaccine; Fluoxetine; Phenilpropanolamin; metilfenilato; troglitazone; Gemfibrozil; Cerivastatina 9. Known history of motor or sensorial Neuropathy, grade I in the NCI-CTC scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine and compare the time to progression of the disease and the objective rate of answer between two treatment arms, in patients with advanced breast cancer. Arm 1: Vinorelbine and Epirubicine Arm 2: Epirubicine and Docetaxel;Secondary Objective: To evaluate the safety and toxicity between the treatment arms. To determine the pharmacoeconomic study for both treatment arms.;Primary end point(s): To determine the activity of the better combination (Arm 1 or arm 2) following the rate of answer and the time to progression disease. | — |
Countries
Spain
Outcome results
None listed