Retrospective Observational Trial on Reasons for Withdraw... | NCT00727883

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

NCT00727883

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 10, 2010Estimated

Enrollment

190Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 1, 2008

First Posted Date

Aug 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2010

Last Update Posted Date

Dec 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Label	Type	Description	Intervention Names
1		Post menopausal women treated with adjuvant TAM for breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs		January 2003-December 2004

Secondary Outcomes

Measure	Description	Time Frame
Types of TAM related AE		January 2003-December 2004

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Post menopausal women treated with adjuvant TAM for breast cancer

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided