on-Interventional study to review the guideline-conform dosage of chemotherapy with taxanes Eurotere® / Eurotaxel® as a monotherapy or combined therapy in everyday use for treatment of breast cancer depending on the age and the body surface
- Conditions
- C50Malignant neoplasm of breast
- Registration Number
- DRKS00009299
- Lead Sponsor
- apharm GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
• Histologically confirmed mamma carcinoma
• Age: = 18 Years
• Signed patient consent form
• Therapy in practice, which belongs to BNGO
Exclusion Criteria
• Pregnancy, breastfeeding period
• Poor Compliance
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Progression Free Survival (PFS) - timeframe: observation phase for 9 months per patient
- Secondary Outcome Measures
Name Time Method • influence of age (= 65 years versus > 65 years) and of body surface on dosage<br>• influence of BMI ( < 19 kg/m² versus 19 - 30 kg/m² versus > 30 kg/m²) on therapy and PFS<br>• tolerability on the NCI CTCAE criteria<br>• efficacy based on the objective response rate<br><br>Measuring times: 1. first prescription of Eurotere(R) / Eurotaxel(R) as part of the NIS, 2. 90 days after the first prescription of Eurotere(R) / Eurotaxel(R), 3. nine months after the first prescription of Eurotere(R) / Eurotaxel(R)<br><br>