NCT00880711

Brief Summary

The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

Enrollment Period

1.4 years

First QC Date

April 10, 2009

Last Update Submit

November 29, 2011

Conditions

Breast Cancer

Keywords

FionaFaslodexAdvanced Breast CancerReal life dataCollect real life data in clinical practice across Austria

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease

    Baseline, after 3, 6, 9 month

Secondary Outcomes (3)

  • Tolerability

    After 3, 6, 9 month (as per usual clinical practice)

  • Quality of Life

    Baseline, after 3, 6, 9 month (as per usual clinical practice)

  • Performance status (Karnofsky Index)

    Baseline, after 3, 6, 9 month (as per usual clinical practice)

Study Arms (1)

1

Patient with advanced BC, already receiving Faslodex therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitals, office based specialists

You may qualify if:

  • Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
  • Ability to read and write and complete questionnaires
  • Provision of written informed consent
  • Patients who already received a prescription for fulvestrant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Graz, Austria

Location

Research Site

Innsbruck, Austria

Location

Research Site

Klagenfurt, Austria

Location

Research Site

Leoben, Austria

Location

Research Site

Linz, Austria

Location

Research Site

Oberpullendorf, Austria

Location

Research Site

Rankweil, Austria

Location

Research Site

Rottenmann, Austria

Location

Research Site

Salzburg, Austria

Location

Research Site

Sankt Veit im Pongau, Austria

Location

Research Site

Steyr, Austria

Location

Research Site

Vienna, Austria

Location

Research Site

Wiener Neustadt, Austria

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Guenther Steger, Univ Prof. Dr.

    Medical University of Vienna

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 14, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

AU(13)