Early Breast CancerE-SAFENCT00558168
Electronic Study for Anastrozole Pharmacovigilance Evaluation
An observational study of Early Breast Cancer, run by AstraZeneca.
Trial summary
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Early Breast Cancer
- How many people
- 1,850 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jul 2008
- 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
- Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.
Who cannot join
- Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
About this study
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer
- Conditions
- Early Breast Cancer
- Keywords
- Anastrazole, safety, early breast cancer
- 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 posted14 Nov 2007 (estimated)
- Study startJan 2004
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- 1,850 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nejdet Uskent, Principal investigator, Kadir Has University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558168
- Sponsor's protocol ID
- ARI-IPEP-0104
- Acronym
- E-SAFE
- Status last verified
- Jul 2008
- First submitted
- 13 Nov 2007
- Last updated
- 28 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Study for Anastrozole Pharmacovigilance Evaluation
- ClinicalTrials.gov ID
- NCT00558168
- Acronym / sponsor ID
- E-SAFE / ARI-IPEP-0104
- Conditions
- Early Breast Cancer
- Keywords
- Anastrazole, safety, early breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,850 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Jul 2008 (actual)
- First posted
- 14 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.
Collecting information regarding adverse events from patients on treatment with anastrazole with early stage breast cancer
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal Early Invasive Breast Cancer Patients who are under anastrazole treatment, who have normal renal and hepatic functions.
Key exclusion criteria (1 listed)
- Metastatic breast cancer patients, previous hormonal therapy, other malignancies.
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 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 28 Jul 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.
Nejdet Uskent principal investigator
Kadir Has University Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Early 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 28 Jul 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.
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 28 Jul 2008.