Post MenopausalNCT00660244
Breast Cancer Tumor Care Observational Programme
An observational study of Post Menopausal and Arthralgia, run by AstraZeneca at 1 site in Austria.
Trial summary
The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Menopausal, Arthralgia
- What is being tested?
- anastrozole
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2008to Dec 2009
- 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 women
Who may be able to join
- Postmenopausal women
- Already on upfront Arimidex Therapy (Start 1-4 weeks before)
- HR+
Who cannot join
- Premenopausal women
- Tamoxifen switch patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Cancer Tumor Care Patient Observation Programme
The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.
- Conditions
- Post Menopausal, Arthralgia
- Being tested
- anastrozole
- Keywords
- Arimidex, Post menopausal, arthralgia
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
Also called Arimidex
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of disease and tolerability in general
Measured: Baseline, every 3 month
Secondary outcomes (1)
Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia
Measured: Baseline, every 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startFeb 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post MenopausalStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Melichart, Study chair, Hospital RudolfstiftungDr. Feistauer, Study chair, AKH-Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660244
- Sponsor's protocol ID
- NIS-OAT-ARI-2007/1
- Status last verified
- Jun 2012
- First submitted
- 15 Apr 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
- Breast Cancer Tumor Care Patient Observation Programme
- ClinicalTrials.gov ID
- NCT00660244
- Acronym / sponsor ID
- NIS-OAT-ARI-2007/1
- Conditions
- Post Menopausal, Arthralgia
- Keywords
- Arimidex, Post menopausal, arthralgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Apr 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 investigate efficacy and tolerability under anastrozole (Arimidex) treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: anastrozole |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (3 listed)
- Postmenopausal women
- Already on upfront Arimidex Therapy (Start 1-4 weeks before)
- HR+
Key exclusion criteria (2 listed)
- Premenopausal women
- Tamoxifen switch patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anastrozoleAlso: ArimidexOral | Drug | 1 |
Primary outcome
Progression of disease and tolerability in general
Time frame: Baseline, every 3 month
1 secondary outcome
Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia
Time frame: Baseline, every 3 month
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.
Dr. Melichart study chair
Hospital Rudolfstiftung
Dr. Feistauer study chair
AKH-Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Menopausal and Arthralgia, run by AstraZeneca at 1 site 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 3 inclusion and 2 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 1 site 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?
Progression of disease and tolerability in general (time frame: Baseline, every 3 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 6 Jun 2012.