Abraxane in Treatment of Metastatic Breast Cancer

NCT ID: NCT02555696

Last Updated: 2017-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nab-paclitaxel

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

nab-paclitaxel

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nab-paclitaxel

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Abraxane ABI-007

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guenter Voraberger

Role: STUDY_CHAIR

Celgene

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LKH Feldkirch

Feldkirch, , Austria

Site Status

Medical University Graz

Graz, , Austria

Site Status

Medical University Innsbruck

Innsbruck, , Austria

Site Status

LKH Leoben

Leoben, , Austria

Site Status

KH Barmherzige Schwestern Linz

Linz, , Austria

Site Status

LKH Salzburg

Salzburg, , Austria

Site Status

LKH St. Pölten

Sankt Pölten, , Austria

Site Status

LKH Steyr

Steyr, , Austria

Site Status

Medical University Vienna

Vienna, , Austria

Site Status

KH SMZ Ost

Vienna, , Austria

Site Status

LKH Vöcklabruck

Vöcklabruck, , Austria

Site Status

Klinikum Wels

Wels, , Austria

Site Status

LKH Wr. Neustadt

Wiener Neustadt, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIPMS-Celgene-AUT-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.