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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult female patients with MBC | This is an observational study, no interventions are specified |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Progression (TTP) | 6 months after last-patient-in (LPI) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 6 months after last-patient-in (LPI) | |
| Overall survival (OS) | 6 months after last-patient-in (LPI) | |
| Time to treatment discontinuation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult female patients with metastatic breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Salat, Prof. | Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| iOMEDICO AG | Freiburg im Breisgau | Baden-Wurttemberg | 79108 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 6 months after last-patient-in (LPI) |
| Number of participants with Adverse Events as a measure of safety and tolerability | Until 30 days after discontinuation of Nab-paclitaxel |
| Relative dosage of Nab-Paclitaxel | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| Intensity of peripheral neuropathy | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| Occurence of neutropenia | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics) | 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. | At baseline, 3 and 6 months after start of treatment |
| Reasons for dose modifications or discontinuation of treatment | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| Occurence of febrile neutropenia | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| Occurence of peripheral neuropathy | Until discontinuation of Nab-Paclitaxel, up to 6 month |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |