Breast Cancer Tumor Care Observational Programme | NCT00660244

Studies
Breast Cancer Tumor Care Observational Programme

NCT00660244

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 6, 2012Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Post Menopausal
Arthralgia

Interventions

anastrozole

Countries

Austria

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

Jun 2012

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

Feb 2008

Primary Completion Date

Not provided

Completion Date

Dec 2009Actual

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 15, 2008

First Posted Date

Apr 17, 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

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

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

150Actual

Label	Type	Description	Intervention Names
1			Drug: anastrozole

Name	Type	Description	Arm Group Labels	Other Names
anastrozole	Drug	Oral	1	Arimidex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression of disease and tolerability in general		Baseline, every 3 month

Secondary Outcomes

Measure	Description	Time Frame
Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia		Baseline, every 3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women
Already on upfront Arimidex Therapy (Start 1-4 weeks before)
HR+

Exclusion Criteria:

Premenopausal women
Tamoxifen switch patients

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

Postmenopausal women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Melichart	Hospital Rudolfstiftung	Study Chair
Dr. Feistauer	AKH-Vienna	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Graz			Austria

Condition Browse Module

MeSH Terms

ID	Term
D018771	Arthralgia

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077384	Anastrozole

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided