Breast CancerARIESNCT00542594
Survey in Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy
An observational study of Breast Cancer, run by AstraZeneca.
Trial summary
The purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,840 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jun 2011
- 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: Woman seen by their physician in the current care setting and for whom a treatment with anastrozole is decided by the physician (adjuvant treatment of breast cancer in postmenopausal women with hormone receptor positive status)
Who may be able to join
- woman treated with anastrozole as adjuvant therapy for hormone-dependant breast cancer in post-menopausal women with positive hormone-receptors
Who cannot join
None listed.
About this study
Official title: A Report Upon a Cohort of Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy for Hormone-dependant Breast Cancer. Long-term Tolerance Evaluation
The purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, anastrozole
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startNov 2005
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: No results are avaialble as the study did not complete according to the protocol
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
- 1,840 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca France Medical Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542594
- Sponsor's protocol ID
- NIS-OFR-ARI-2005/1
- Acronym
- ARIES
- Status last verified
- Feb 2013
- First submitted
- 9 Oct 2007
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Report Upon a Cohort of Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy for Hormone-dependant Breast Cancer. Long-term Tolerance Evaluation
- ClinicalTrials.gov ID
- NCT00542594
- Acronym / sponsor ID
- ARIES / NIS-OFR-ARI-2005/1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, anastrozole
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No results are avaialble as the study did not complete according to the protocol
- Enrolment
- 1,840 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Oct 2007 (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 survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.
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
- Woman seen by their physician in the current care setting and for whom a treatment with anastrozole is decided by the physician (adjuvant treatment of breast cancer in postmenopausal women with hormone receptor positive status)
Key inclusion criteria (1 listed)
- woman treated with anastrozole as adjuvant therapy for hormone-dependant breast cancer in post-menopausal women with positive hormone-receptors
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: No results are avaialble as the study did not complete according to the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
AstraZeneca France Medical Director study director
AstraZeneca
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: stopped early, as of the sponsor's last update on 7 Feb 2013. 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 was stopped early (reason given: No results are avaialble as the study did not complete according to the protocol). Results are not available in the source record.
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.
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 7 Feb 2013.