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

AstraZeneca

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.

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3
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