Arimidex Observational: Reason for and Effect of Change F... | NCT00246961 | Trialant

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Arimidex Observational: Reason for and Effect of Change F... | NCT00246961 | Trialant

Studies
Arimidex Observational: Reason for and Effect of Change From Tamoxifen

NCT00246961

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 12, 2007Estimated

Enrollment

200

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Netherlands

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

NCT00246961

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

D5392NL0002

Secondary IDs

ID	Type	Description	Link
ARREST

Brief Title

Arimidex Observational: Reason for and Effect of Change From Tamoxifen

Official Title

Arimidex: Reason for and Effect of Change From Tamoxifen

Acronym

ARREST

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 31, 2005

First Submission Date that Met QC Criteria

Oct 31, 2005

First Posted Date

Nov 1, 2005Estimated

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

Oct 11, 2007

Last Update Posted Date

Oct 12, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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

Description Module

Brief Summary

The purpose of this study is to analyse the effect on quality of life after 3 months of treatment after changing adjuvant therapy from tamoxifen to Arimidex.

Detailed Description

Not provided

Conditions Module

Conditions

Breast Cancer

Keywords

Adjuvant

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

200

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal
Hormone sensitive breast cancer
Patient uses tamoxifen or has stopped taking tamoxifen less than 7 days ago

Exclusion Criteria:

Visceral metastases
Patients with signs of progression at the moment of changing therapy
Patients who have used other endocrine treatments for breast cancer besides tamoxifen

Accepts Healthy Volunteers

No

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca The Netherlands Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		's-Hertogenbosch			Netherlands
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Alkmaar

Netherlands

Research Site

Antwerpen

Netherlands

Research Site

Apeldoorn

Netherlands

Research Site

Bergen op Zoom

Netherlands

Research Site

Boxmeer

Netherlands

Research Site

Breda

Netherlands

Research Site

Doetinchem

Netherlands

Research SIte

Dordrecht

Netherlands

Research Site

Ede

Netherlands

Research Site

Eindhoven

Netherlands

Research Site

Enschede

Netherlands

Research Site

Flushing

Netherlands

Research Site

Geldrop

Netherlands

Research Site

Groningen

Netherlands

Research Site

Harderwijk

Netherlands

Research Site

Helmond

Netherlands

Research Site

Hoogeveen

Netherlands

Research Site

Hoorn

Netherlands

Research Site

Leiden

Netherlands

Research Site

Oosterhout

Netherlands

Research Site

Purmerend

Netherlands

Research Site

Roermond

Netherlands

Research Site

Roosendaal

Netherlands

Research Site

Rotterdam

Netherlands

Research Site

Schiedam

Netherlands

Research Site

Terneuzen

Netherlands

Research Site

The Hague

Netherlands

Research Site

Tiel

Netherlands

Research Site

Venray

Netherlands

Research Site

Winterswijk

Netherlands

Research Site

Zoetermeer

Netherlands

Research Site

Zutphen

Netherlands

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided