Abraxane in Treatment of Metastatic Breast Cancer

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: nab-paclitaxel

• Registration Number: NCT02555696
• Lead Sponsor: Celgene

Brief Summary

This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.

Detailed Description

This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.

A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.

This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).

Study Timeline

• Study Start: 2012-05-31
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-21
• Primary Completion: 2016-02-28
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

1. Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
2. Signed Informed Consent
3. Participants > 18 Years of Age

Exclusion Criteria

1. Pregnant or lactating females
2. Neutrophils <1.5 X 10^9/L
3. Hypersensivity to nab-paclitaxel

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nab-paclitaxel	nab-paclitaxel	nab-paclitaxel 260mg/m\^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 3 years	Includes the number of participants with adverse events

Secondary Outcome Measures

Name	Time	Method
Overall Response	Up to 3 years	Number of participants who achieve a response

Trial Locations

Locations (13)

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

LKH Salzburg; 🇦🇹 Salzburg, Austria

KH SMZ Ost; 🇦🇹 Vienna, Austria

LKH Vöcklabruck; 🇦🇹 Vöcklabruck, Austria

Klinikum Wels; 🇦🇹 Wels, Austria

Medical University Graz; 🇦🇹 Graz, Austria

LKH Feldkirch; 🇦🇹 Feldkirch, Austria

LKH Steyr; 🇦🇹 Steyr, Austria

Medical University Vienna; 🇦🇹 Vienna, Austria

LKH Wr. Neustadt; 🇦🇹 Wr. Neustadt, Austria

LKH Leoben; 🇦🇹 Leoben, Austria

KH Barmherzige Schwestern Linz; 🇦🇹 Linz, Austria

LKH St. Pölten; 🇦🇹 St. Pölten, Austria