Breast CancerRADAR II ENCT00692289
Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca at 6 sites in Hungary.
Trial summary
This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,510 participants
- Where
- 6 sitesHungary
- Study dates
- Jun 2008to Jul 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: Postmenopausal, hormonreceptor positive patients with early breast cancer treated with Arimidex (in accordance with the local SmPC).
Who may be able to join
- Provision of informed consent
- Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex
- Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.
Who cannot join
- Allergy to substance of medication
- Pre-perimenopausal woman
- Woman not eligible for treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Hungary6 sites
Research Site
Budapest
Research Site
Komló
Research Site
Miskolc
Research Site
Mohács
Research Site
Vác
Research Site
Zalaegerszeg
About this study
This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire
- Conditions
- Breast Cancer
- Keywords
- Quality of Life
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Elements of the investigator questionnaire SF RAND-36 questionnaire
Measured: Quarterly (plus or minus 3 days )
Secondary outcomes (1)
Investigator Assessment Report
Measured: Yearly (plus or minus 1 week )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,510 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zsolt Horváth, M.D., Principal investigator, National Institute of OncologyCsaba Csongvai, Study director, AstraZeneca HungaryÉva Gulyás, Study chair, AstraZeneca Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692289
- Sponsor's protocol ID
- NIS-OHU-ARI-2007/1
- Acronym
- RADAR II E
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2008
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00692289
- Acronym / sponsor ID
- RADAR II E / NIS-OHU-ARI-2007/1
- Conditions
- Breast Cancer
- Keywords
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,510 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Jun 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.
This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal, hormonreceptor positive patients with early breast cancer treated with Arimidex (in accordance with the local SmPC).
Key inclusion criteria (3 listed)
- Provision of informed consent
- Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex
- Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.
Key exclusion criteria (3 listed)
- Allergy to substance of medication
- Pre-perimenopausal woman
- Woman not eligible for treatment
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
Elements of the investigator questionnaire SF RAND-36 questionnaire
Time frame: Quarterly (plus or minus 3 days )
1 secondary outcome
Investigator Assessment Report
Time frame: Yearly (plus or minus 1 week )
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 6 Jun 2012.
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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.
Zsolt Horváth, M.D. principal investigator
National Institute of Oncology
Csaba Csongvai study director
AstraZeneca Hungary
Éva Gulyás study chair
AstraZeneca Hungary
6 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 6 sites in Hungary.
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 3 inclusion and 3 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hungary. 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?
Elements of the investigator questionnaire SF RAND-36 questionnaire (time frame: Quarterly (plus or minus 3 days )). 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 6 Jun 2012.