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

Metastatic Breast Cancer Clinical Trial

— NABUCCO  

Official title:

Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689610
• Other study ID #: IOM-02240
• Status: Completed
• Start date: April 2012
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: iOMEDICO AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 705
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Germany	iOMEDICO AG	Freiburg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tumor Progression (TTP)		6 months after last-patient-in (LPI)
Secondary	Overall Response Rate (ORR)		6 months after last-patient-in (LPI)
Secondary	Overall survival (OS)		6 months after last-patient-in (LPI)
Secondary	Time to treatment discontinuation		6 months after last-patient-in (LPI)
Secondary	Number of participants with Adverse Events as a measure of safety and tolerability		Until 30 days after discontinuation of Nab-paclitaxel
Secondary	Relative dosage of Nab-Paclitaxel		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	Intensity of peripheral neuropathy		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	Occurence of neutropenia		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	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
Secondary	Reasons for dose modifications or discontinuation of treatment		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	Occurence of febrile neutropenia		Until discontinuation of Nab-Paclitaxel, up to 6 month
Secondary	Occurence of peripheral neuropathy		Until discontinuation of Nab-Paclitaxel, up to 6 month