Non-interventional Study With Nab-Paclitaxel (Abraxane®)
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Nab-Paclitaxel, Abraxane, Nabucco, safety, breast cancer, daily routine, peripheral neuropathy, iOMEDICO
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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?
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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.
Location
iOMEDICO AG
Freiburg, Baden-Wuerttemberg, Germany
Status: Recruiting
Contact: iOMEDICO AG - +49 761 15 242 - info@iomedico.com
Start Date
April 2012
Completion Date
April 2015
Sponsors
iOMEDICO AG
Source
iOMEDICO AG
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page