Advanced Breast CancerNCT00562458
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer
An observational study of Advanced Breast Cancer, run by AstraZeneca.
Trial summary
To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- anastrozole
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to not given
- 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 patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
Who may be able to join
- Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.
Who cannot join
- Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.
About this study
Official title: ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)
To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
- Conditions
- Advanced Breast Cancer
- Being tested
- anastrozole
- Keywords
- Advanced breast cancer, Advanced breast cancer in postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562458
- Sponsor's protocol ID
- NIS-ARO-HCH-2006/1
- Status last verified
- Feb 2013
- First submitted
- 21 Nov 2007
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARIMIDEX Study ( Non-interventional Study to Evaluate Arimidex in Adjuvant Therapy in Partial or Complete Response or Stabilized Disease After First Line Chemotherapy in Postmenopausal Women With Advanced Breast Cancer)
- ClinicalTrials.gov ID
- NCT00562458
- Acronym / sponsor ID
- NIS-ARO-HCH-2006/1
- Conditions
- Advanced Breast Cancer
- Keywords
- Advanced breast cancer, Advanced breast cancer in postmenopausal women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 22 Nov 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.
To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.
Key inclusion criteria (1 listed)
- Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.
Key exclusion criteria (1 listed)
- Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.
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 |
|---|---|---|
| anastrozole | Drug | – |
Primary outcome
Not reported in the source record.
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 5 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced 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 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 5 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 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.
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 5 Feb 2013.