Study to assess the efficacy and safety of oral vinorelbine in combination with capecitabine in patients suffering from breast cancer previously treated with other chemotherapies (anthracyclines, and taxanes)
- Conditions
- Treatment in metastatic breast cancer women previously treated with anthracyclines and taxanesTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2004-000665-35-ES
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
Women aged 18 to 75 years, documented metastatic breast disease, at least one bidimensionally measurable lesion adequately measured by imaging procedure, previously treated with anthracyclines and taxanes, Karnofsky performance status of 70 or greater, adequate haematological, hepatic and renal functions.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
Patient with poor prognosis disease, pregnant or lacting or of childbearing potential not using adequate contraception, malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade 2 or more dysphagia, other serious illness or medical conditions.
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