Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
Completed
- Conditions
- Metastatic Breast CancerNon Small Cell Lung Carcinoma
- Registration Number
- NCT00890903
- Lead Sponsor
- Pierre Fabre Pharma GmbH
- Brief Summary
The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
- At least 18 years old
- Male and female patients
- Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC
- Therapy with Navelbine capsules in any palliative treatment line
- Signed patient informed consent
Exclusion Criteria
- Pregnancy and nursing
- All other exclusion criteria listed in SPC (summary of product characteristics)
- lack of signed Patient informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free-survival 1 year after LPI
- Secondary Outcome Measures
Name Time Method Adverse reactions 1 year after LPI Time to progression 1 year after LPI Therapy performance in the daily routine 1 year after LPI Concomitant antiemetic therapy 1 year after LPI Recording of combinations of applied capsules (requested by a patients' questionnaire) 1 year after LPI General condition of patients (requested by a patients' questionnaire) 1 year after LPI Patient compliance 1 year after LPI
Trial Locations
- Locations (1)
Pierre Fabre Pharma GmbH
🇩🇪Freiburg, Germany