'Pilot trial of Pegilated Liposomal Doxorrubicin (Caelyx) in combination with Docetaxel (Taxotere) in advanced breast cancer patients'Estudio Piloto de Doxorrubicina Liposomal Pegilada (Caelyx) en combinación con Docetaxel (Taxotere) en pacientes con cáncer de mama avanzado
- Conditions
- Advanced Breast Cancer
- Registration Number
- EUCTR2005-001499-10-ES
- Lead Sponsor
- Dr. José Ramón Mel Lorenzo
- 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
Aged > 18 years
Histologic diagnostic of breast cancer
Performance status of Karnofsky > 60%
Left ventricular ejecction > 50%
Hepatic and medular funtions adecuated
Mensurable lesions of metastatic breast cancer
No previous chemotherapy treatments for metastasic disease
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
No cardiopathy history
No hipersensibility for antraciclines therapy
No treatment failure to antraciclines therapy in previous 12 months
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