Breast CancerAx-003NCT00638391
Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer
An observational study of Breast Cancer, run by AstraZeneca.
Trial summary
The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Mar 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
Who may be able to join
- Postmenopausal women with early hormone receptor positive breast cancer/no metastasis
Who cannot join
- None
About this study
Official title: Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis
The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole.
- Conditions
- Breast Cancer
- Being tested
- Anastrozole
- Keywords
- Primary early MCa, Arimidex
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
| Study group | Role | What they receive |
|---|---|---|
| 1 | all patients treated with Anastrozole Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions
Measured: 12 months
Secondary outcomes (2)
description of population treated with anastrozole
Measured: 12 months
further information about the change of specific laboratory parameters
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startMay 2005
- Study completionMar 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H Brasch, Study director, AstraZeneca Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638391
- Sponsor's protocol ID
- Ax-003
- Other IDs
- Ax-003/Arimidex
- Acronym
- Ax-003
- Status last verified
- Mar 2008
- First submitted
- 13 Mar 2008
- Last updated
- 20 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis
- ClinicalTrials.gov ID
- NCT00638391
- Acronym / sponsor ID
- Ax-003 / Ax-003
- Conditions
- Breast Cancer
- Keywords
- Primary early MCa, Arimidex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 19 Mar 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 the initial/followed by 5 year adjuvant therapy with Anastrozole.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Anastrozoleall patients treated with Anastrozole |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with early hormone receptor positive breast cancer/no metastasis
Key exclusion criteria (1 listed)
- None
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: Arimidex | Drug | 1 |
Primary outcome
evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions
Time frame: 12 months
2 secondary outcomes
description of population treated with anastrozole
Time frame: 12 months
further information about the change of specific laboratory parameters
Time frame: 12 months
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 20 Mar 2008.
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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.
H Brasch study director
AstraZeneca Germany
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 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 20 Mar 2008. 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?
evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions (time frame: 12 months). 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 20 Mar 2008.