Abraxane in Treatment of Metastatic Breast Cancer

February 22, 2017 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6800:
        • LKH Feldkirch
      • Graz, Austria, 8036:
        • Medical University Graz
      • Innsbruck, Austria, 6020:
        • Medical University Innsbruck
      • Leoben, Austria, 8700:
        • LKH Leoben
      • Linz, Austria, 4020:
        • KH Barmherzige Schwestern Linz
      • Salzburg, Austria, 5020:
        • LKH Salzburg
      • St. Pölten, Austria, 3100:
        • LKH St. Pölten
      • Steyr, Austria, 4400:
        • LKH Steyr
      • Vienna, Austria, 1090:
        • Medical University Vienna
      • Vienna, Austria, 1220:
        • KH SMZ Ost
      • Vöcklabruck, Austria, 4840:
        • Lkh Vöcklabruck
      • Wels, Austria, 4600:
        • Klinikum Wels
      • Wr. Neustadt, Austria, 2700:
        • LKH Wr. Neustadt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
nab-paclitaxel
nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity
Drug: nab-paclitaxel
nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity
Other Names:
  • ABI-007
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to 3 years
Includes the number of participants with adverse events
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response
Time Frame: Up to 3 years
Number of participants who achieve a response
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Chair: Guenter Voraberger, Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2012

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPMS-Celgene-AUT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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