Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients (SOSTA)
December 9, 2010 updated by: AstraZeneca
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
190
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Post menopausal women treated with adjuvant TAM for breast cancer
Description
Inclusion Criteria:
- Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
- Documented reasons for treatment withdrawal
Exclusion Criteria:
- enrollment in other studies
- treatment withdraw for other causes than Tam related AEs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
Post menopausal women treated with adjuvant TAM for breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs
Time Frame: January 2003-December 2004
|
January 2003-December 2004
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Types of TAM related AE
Time Frame: January 2003-December 2004
|
January 2003-December 2004
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (ACTUAL)
May 1, 2008
Study Completion (ACTUAL)
May 1, 2008
Study Registration Dates
First Submitted
July 31, 2008
First Submitted That Met QC Criteria
August 1, 2008
First Posted (ESTIMATE)
August 4, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 10, 2010
Last Update Submitted That Met QC Criteria
December 9, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-OIT-DUM-2006/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.