Breast CancerSOSTANCT00727883
Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
An observational study of Breast Cancer, run by AstraZeneca.
Trial summary
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to May 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
Study population: Post menopausal women treated with adjuvant TAM for breast cancer
Who may be able to join
- Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
- Documented reasons for treatment withdrawal
Who cannot join
- enrollment in other studies
- treatment withdraw for other causes than Tam related AEs
About this study
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Adjuvant TAM, post-menopausal, women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Post menopausal women treated with adjuvant TAM for breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs
Measured: January 2003-December 2004
Secondary outcomes (1)
Types of TAM related AE
Measured: January 2003-December 2004
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
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
- Retrospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727883
- Sponsor's protocol ID
- NIS-OIT-DUM-2006/1
- Acronym
- SOSTA
- Status last verified
- Dec 2010
- First submitted
- 31 Jul 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00727883
- Acronym / sponsor ID
- SOSTA / NIS-OIT-DUM-2006/1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Adjuvant TAM, post-menopausal, women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 4 Aug 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.
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Post menopausal women treated with adjuvant TAM for breast cancer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Post menopausal women treated with adjuvant TAM for breast cancer
Key inclusion criteria (2 listed)
- Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
- Documented reasons for treatment withdrawal
Key exclusion criteria (2 listed)
- enrollment in other studies
- treatment withdraw for other causes than Tam related AEs
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
incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs
Time frame: January 2003-December 2004
1 secondary outcome
Types of TAM related AE
Time frame: January 2003-December 2004
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 10 Dec 2010.
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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 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 2 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 10 Dec 2010. 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?
incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs (time frame: January 2003-December 2004). 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 10 Dec 2010.