Metastatic Breast Cancer
Conditions
Keywords
Nab-Paclitaxel, Abraxane, Nabucco, safety, breast cancer, daily routine, peripheral neuropathy, iOMEDICO
Brief summary
The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.
Detailed description
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?
Interventions
None listed
Sponsors
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)
Exclusion criteria
* Contraindication according to the summary of product characteristics of Abraxane® * No signed patient informed consent form available * pregnant or breastfeeding patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Tumor Progression (TTP) | 6 months after last-patient-in (LPI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 6 months after last-patient-in (LPI) | — |
| Time to treatment discontinuation | 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 | — |
| Overall Response Rate (ORR) | 6 months after last-patient-in (LPI) | — |
| 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 | At baseline, 3 and 6 months after start of treatment | Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute. |
| 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 | — |
| Occurence of neutropenia | Until discontinuation of Nab-Paclitaxel, up to 6 month | — |
Countries
Germany
Outcome results
None listed