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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00727883
First received: July 31, 2008
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs [ Time Frame: January 2003-December 2004 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Types of TAM related AE [ Time Frame: January 2003-December 2004 ] [ Designated as safety issue: Yes ]

Enrollment: 190
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Post menopausal women treated with adjuvant TAM for breast cancer

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Post menopausal women treated with adjuvant TAM for breast cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Davide Meani Specialty Medical Affairs Manager, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00727883     History of Changes
Other Study ID Numbers: NIS-OIT-DUM-2006/1
Study First Received: July 31, 2008
Last Updated: December 9, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by AstraZeneca:
Breast Cancer
Adjuvant TAM
post-menopausal
women

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014