A phase II study of Capecitabine in combination with oral vinorelbine in advanced Breast Cancer - ND
- Conditions
- advancer breast carcinomaMedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasm
- Registration Number
- EUCTR2006-003752-38-IT
- Lead Sponsor
- OSPEDALE ONCOLOGICO DI BARI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
1. Histologically or cytologically proven advanced breast carcinoma
2. Patients pretreated with taxanes plus/minus anthracyclines
3. Age >18 and < 75 years
4. Life expectancy > 3 months
5. Normal cardiac function
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
Exclusion Criteria
1. History of prior malignancy in the last 10 years
2. Symptomatic peripheral neuropathy
3. Other serious illness or medical condition
4. Concurrent treatment with other experimental drugs
5. ASAT (SGOT) and/or ALAT (SGPT) > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL
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