A Randomised Phase II study of Oral Vinorelbine or I.V. Vinorelbine in patients with metastatic breast cancer previously treated with anthracyclines
- Conditions
- Treatment in metastatic breast cancer previously treated with anthracyclines
- Registration Number
- EUCTR2004-000963-81-BE
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 230
- Women over 65 years
- Prior therapy with anthracyclines
- Documented metastatic breast cancer
- Karnofsky Performance Status not less than 70%
- Presence of at least one measurable lesion according to RECIST criteria
- Adequate haematological, hepatic and renal function
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
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
- Patients with life-threatening conditions
- Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach, proximal small bowel or grade not less than 2 dysphagia
- Other serious illness or medical condition
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