A multicenter, phase II clinical trial comparing Vinorelbine and Epirubicine versus Epirubicine and docetaxel in First Line of treatment for women with breast cancerEstudio fase II, abierto, multicéntrico, randomizado de Vinorelbina y Epirubicina versus Docetaxel y Epirubicina en primera línea de cáncer de mama avanzado - GON40-04-Breast

GON-North Oncology Group0 个研究点目标入组 120 人开始时间: 2005年7月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

GON-North Oncology Group