VINORELBINE AND CAPECITABINE as first line treatment in advanced breast cancer patients with non measurable lesions for RECIST criteria - VNBCAP
- Conditions
- metastatic breast cancerMedDRA version: 6.1Level: PTClassification code 10055113
- Registration Number
- EUCTR2005-005680-29-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA S. LUIGI GONZAGA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
metastatic breast carcinoma non measurable lesions for RECIST criteria progression after loco-regional therapy
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
previous first line chemotherapy previous second and third line hormonotherapy for advanced disease diagnosis of advanced disease with only elevated markers
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: time to progression;Secondary Objective: toxicity quality of life overall survival;Primary end point(s): time to progression from th entry into the study until first clinial or instrumental disease progression
- Secondary Outcome Measures
Name Time Method