Ensayo clínico en fase I-II de vinorelbina oral (Navelbine) en combinación con capecitabina en tratamiento de primera línea en pacientes con cáncer de mama avanzado - Not applicable
- Conditions
- Advanced breast cancer (metastatic)
- Registration Number
- EUCTR2004-000602-44-ES
- Lead Sponsor
- Pierre Fabre Ibérica, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 63
- Histological or cytologically confirmed advanced breast carcinoma (metastatic)
- Informed consent prior to the inclusion
- Age = 18 and = 70 years old
- ECOG-OMS: 0, 1 or 2
- 1rst line of chemotherapy at phase II. At phase I patients could have received chemotherapy for advanced disease.
- Life expectancy › 3 months
- Adequate bone marrow/haematological function
- Adequate hepatic and renal function
- At least one measurable or evaluable LESION according to RECIST criteria at phase I.
- At least one measurable LESION according to RECIST criteria at phase II.
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) yes
F.1.3.1 Number of subjects for this age range
-At phase II previous chemotherapy treatment for metastatic disease
- Concurrent treatment with any other anti-cancer therapy
- Pregnant or lactating or childbearing potential not using medically accepted contraception
- Active disease of the central nervous system or brain or leptomeningealmetastasis
- Patients with diabetic unbalance, uncontrolled high blood pressure, unbalanced heart failure, peptic ulcer, lack of alimentary canal integrity or malabsortion syndrome.
- Active and uncontrolled infection
- Peripheral neuropathy = grade 2 using NCI criteria
- Malabsortion syndrome, major gastric resection or any other disease that affects the funtinallity of the gastrointestinal tractus
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Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method