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NCT02555696 Clinical Trial

Abraxane in Treatment of Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02555696
Other study ID # NIPMS-Celgene-AUT-002
Secondary ID
Status Completed
Phase N/A
First received September 18, 2015
Last updated February 22, 2017
Start date May 31, 2012
Est. completion date December 31, 2016

Study information
Verified date February 2017
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date December 31, 2016
Est. primary completion date February 28, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• nab-paclitaxel
nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity

Locations
Country Name City State
Austria LKH Feldkirch Feldkirch
Austria Medical University Graz Graz
Austria Medical University Innsbruck Innsbruck
Austria LKH Leoben Leoben
Austria KH Barmherzige Schwestern Linz Linz
Austria LKH Salzburg Salzburg
Austria LKH St. Pölten St. Pölten
Austria LKH Steyr Steyr
Austria KH SMZ Ost Vienna
Austria Medical University Vienna Vienna
Austria LKH Vöcklabruck Vöcklabruck
Austria Klinikum Wels Wels
Austria LKH Wr. Neustadt Wr. Neustadt

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Includes the number of participants with adverse events Up to 3 years
Secondary Overall Response Number of participants who achieve a response Up to 3 years
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