Non-interventional Study With Nab-Paclitaxel (Abraxane®)

Completed

• Conditions: Metastatic Breast Cancer

• Registration Number: NCT01689610
• Lead Sponsor: iOMEDICO AG

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?

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Primary Completion: 2015-11
• Study Completion: 2016-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 705

Inclusion Criteria

• Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)

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Exclusion Criteria

• Contraindication according to the summary of product characteristics of Abraxane®
• No signed patient informed consent form available
• pregnant or breastfeeding patients.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Tumor Progression (TTP)	6 months after last-patient-in (LPI)

Secondary Outcome Measures

Name	Time	Method
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	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	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

Trial Locations

Locations (1)

iOMEDICO AG; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany