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

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ClinicalTrials.gov Identifier: NCT00727883
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients

Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
Study Start Date : July 2007
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
Post menopausal women treated with adjuvant TAM for breast cancer


Outcome Measures

Primary Outcome Measures :
  1. incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs [ Time Frame: January 2003-December 2004 ]

Secondary Outcome Measures :
  1. Types of TAM related AE [ Time Frame: January 2003-December 2004 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
More Information

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
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents