Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Breast Cancer Clinical Trial

— SOSTA  

Official title:

Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727883
• Other study ID #: NIS-OIT-DUM-2006/1
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: December 9, 2010
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs		January 2003-December 2004	Yes
Secondary	Types of TAM related AE		January 2003-December 2004	Yes