on-interventional Study to analyse the tolerability and effectiveness of a chemotherapy with taxanes (Eurotere® / Eurotaxel®) on an everyday basis to treat breast cancer
Recruiting
- Conditions
- C50.9Breast, unspecified
- Registration Number
- DRKS00004212
- Lead Sponsor
- apharm GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 750
Inclusion Criteria
histological secured breast cancer, Age not less then 18 years, signed Patient informed consent, contraception during cytostatic therapy, oncological therapy in doctor´s practice
Exclusion Criteria
pregnancy, other oncological disease, deficient compliance, palliative treatment with taxanes in an earlier treatment except taxanes in neo- or adjuvant therapy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Influence of age; BMI, comorbidities on therapy and tolerance (CTC-Criteria 2.0), therapeutic effect (RECIST)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS), Overall Survival (OS), effect on physical ability (Questions in eCRF)<br><br>- documantation period: 9 month