Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer
- Sponsor
- iOMEDICO AG
- Enrollment
- 705
- Locations
- 1
- Primary Endpoint
- Time to Tumor Progression (TTP)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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?
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Time to Tumor Progression (TTP)
Time Frame: 6 months after last-patient-in (LPI)
Secondary Outcomes
- Overall survival (OS)(6 months after last-patient-in (LPI))
- Overall Response Rate (ORR)(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)
- 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)
- 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)