Abraxane in Treatment of Metastatic Breast Cancer

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Feldkirch, Feldkirch, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nab-paclitaxel

Drug

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

Other names: Abraxane, ABI-007

Primary outcomes

Adverse Events

Time frame: Up to 3 years

Includes the number of participants with adverse events

Secondary outcomes

Overall Response

Time frame: Up to 3 years

Number of participants who achieve a response

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Sep 21, 2015
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed