Breast CancerFIONANCT00880711
Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC)
An observational study of Breast Cancer, run by AstraZeneca at 13 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 57 participants
- Where
- 13 sitesAustria
- Study dates
- Apr 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitals, office based specialists
Who may be able to join
- 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
Who cannot join
- A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Austria13 sites
Research Site
Graz
Research Site
Innsbruck
Research Site
Klagenfurt
Research Site
Leoben
Research Site
Linz
Research Site
Oberpullendorf
Research Site
Rankweil
Research Site
Rottenmann
Research Site
Salzburg
Research Site
Sankt Veit im Pongau
Research Site
Steyr
Research Site
Vienna
Research Site
Wiener Neustadt
About this study
Official title: Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer
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.
- Conditions
- Breast Cancer
- Keywords
- Fiona, Faslodex, Advanced Breast Cancer, Real life data, Collect real life data in clinical practice across Austria
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patient with advanced BC, already receiving Faslodex therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, after 3, 6, 9 month
Secondary outcomes (3)
Tolerability
Measured: After 3, 6, 9 month (as per usual clinical practice)
Quality of Life
Measured: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Performance status (Karnofsky Index)
Measured: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guenther Steger, Univ Prof. Dr., Study chair, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880711
- Sponsor's protocol ID
- NIS-OAT-FAS-2009/1
- Acronym
- FIONA
- Status last verified
- Nov 2011
- First submitted
- 10 Apr 2009
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00880711
- Acronym / sponsor ID
- FIONA / NIS-OAT-FAS-2009/1
- Conditions
- Breast Cancer
- Keywords
- Fiona, Faslodex, Advanced Breast Cancer, Real life data, Collect real life data in clinical practice across Austria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patient with advanced BC, already receiving Faslodex therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals, office based specialists
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Baseline, after 3, 6, 9 month
3 secondary outcomes
Tolerability
Time frame: After 3, 6, 9 month (as per usual clinical practice)
Quality of Life
Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Performance status (Karnofsky Index)
Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guenther Steger, Univ Prof. Dr. study chair
Medical University of Vienna
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 13 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, after 3, 6, 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.