NCT02555696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.7 years

First QC Date

September 18, 2015

Last Update Submit

February 22, 2017

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancernab-paclitaxelAbraxane

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Includes the number of participants with adverse events

    Up to 3 years

Secondary Outcomes (1)

  • Overall Response

    Up to 3 years

Study Arms (1)

nab-paclitaxel

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

Drug: nab-paclitaxel

Interventions

nab-paclitaxelDRUG

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

Also known as: Abraxane, ABI-007
nab-paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic breast cancer

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

LKH Feldkirch

Feldkirch, 6800:, Austria

Location

Medical University Graz

Graz, 8036:, Austria

Location

Medical University Innsbruck

Innsbruck, 6020:, Austria

Location

LKH Leoben

Leoben, 8700:, Austria

Location

KH Barmherzige Schwestern Linz

Linz, 4020:, Austria

Location

LKH Salzburg

Salzburg, 5020:, Austria

Location

LKH St. Pölten

Sankt Pölten, 3100:, Austria

Location

LKH Steyr

Steyr, 4400:, Austria

Location

Medical University Vienna

Vienna, 1090:, Austria

Location

KH SMZ Ost

Vienna, 1220:, Austria

Location

LKH Vöcklabruck

Vöcklabruck, 4840:, Austria

Location

Klinikum Wels

Wels, 4600:, Austria

Location

LKH Wr. Neustadt

Wiener Neustadt, 2700:, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Guenter Voraberger

    Celgene

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 21, 2015

Study Start

May 31, 2012

Primary Completion

February 28, 2016

Study Completion

December 31, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

AU(13)