The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.
The main focus of this non-interventional study is set on answering the following questions: * Can the results observed in controlled clinical trials regarding efficacy and safety be reproduced in the routine clinical setting? * Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the previously described safety-profile in terms of frequency and intensity? * What are the main reasons for modification or termination of the nab-paclitaxel therapy? * How does nab-paclitaxel therapy influence the patients' quality of life? * What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast cancer?
Study Type
OBSERVATIONAL
Enrollment
705
iOMEDICO AG
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Time to Tumor Progression (TTP)
Time frame: 6 months after last-patient-in (LPI)
Overall Response Rate (ORR)
Time frame: 6 months after last-patient-in (LPI)
Overall survival (OS)
Time frame: 6 months after last-patient-in (LPI)
Time to treatment discontinuation
Time frame: 6 months after last-patient-in (LPI)
Number of participants with Adverse Events as a measure of safety and tolerability
Time frame: Until 30 days after discontinuation of Nab-paclitaxel
Relative dosage of Nab-Paclitaxel
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Intensity of peripheral neuropathy
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of neutropenia
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Patient reported outcome on Quality of life and adverse events
Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute.
Time frame: At baseline, 3 and 6 months after start of treatment
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Reasons for dose modifications or discontinuation of treatment
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of febrile neutropenia
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
Occurence of peripheral neuropathy
Time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month