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
- Conditions
- Patients with histologically or citologically confirmed advanced or metastatic breast cancer, no subject to curative local treatment.
- Registration Number
- EUCTR2004-003786-33-ES
- Lead Sponsor
- GON-North Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Arm 1: Vinorelbine and Epirubicine<br>Arm 2: Epirubicine and Docetaxel;Secondary Objective: To evaluate the safety and toxicity between the treatment arms.<br>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.
- Secondary Outcome Measures
Name Time Method