Breast CancerNCT00681369
Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
An observational study of Breast Cancer, run by AstraZeneca.
Trial summary
the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 2007
- 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: Hospital sample
Who may be able to join
- Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007
Who cannot join
None listed.
About this study
the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile
- Conditions
- Breast Cancer
- Keywords
- breast cancer, fulvestrant, longitudinal study, France
- 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 | Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Faslodex therapeutic strategy and treatment duration
Measured: At the end of the study
Describe the characteristics of patients treated with Faslodex
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2007
- Study completionJun 2007
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alain FLINOIS, Principal investigator, TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681369
- Sponsor's protocol ID
- NIS-OFR-FAS-2007/1
- Status last verified
- Jan 2011
- First submitted
- 20 May 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
- ClinicalTrials.gov ID
- NCT00681369
- Acronym / sponsor ID
- NIS-OFR-FAS-2007/1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, fulvestrant, longitudinal study, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 21 May 2008 (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 of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital sample
Key inclusion criteria (1 listed)
- Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007
Key exclusion criteria (0 listed)
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
Evaluate Faslodex therapeutic strategy and treatment duration
Time frame: At the end of the study
Describe the characteristics of patients treated with Faslodex
Time frame: At the end of the study
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 24 Jan 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.
Alain FLINOIS principal investigator
TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca.
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 1 inclusion and 0 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate Faslodex therapeutic strategy and treatment duration (time frame: At the end of the study). The study lists 2 primary outcomes in all. 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 24 Jan 2011.