NCT00727883

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

July 31, 2008

Last Update Submit

December 9, 2010

Conditions

Breast Cancer

Keywords

Breast CancerAdjuvant TAMpost-menopausalwomen

Outcome Measures

Primary Outcomes (1)

  • incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs

    January 2003-December 2004

Secondary Outcomes (1)

  • Types of TAM related AE

    January 2003-December 2004

Study Arms (1)

1

Post menopausal women treated with adjuvant TAM for breast cancer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post menopausal women treated with adjuvant TAM for breast cancer

You may qualify if:

  • Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
  • Documented reasons for treatment withdrawal

You may not qualify if:

  • enrollment in other studies
  • treatment withdraw for other causes than Tam related AEs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 4, 2008

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 10, 2010

Record last verified: 2010-12