Non-interventional Study to Evaluate Arimidex in Postmeno... | NCT00562458

Studies
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer

NCT00562458

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 5, 2013Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Advanced Breast Cancer

Interventions

anastrozole

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

Feb 2013

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

Dec 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 2007Estimated

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

Feb 4, 2013

Last Update Posted Date

Feb 5, 2013Estimated

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

Description Module

Brief Summary

To evaluate Arimidex 6 month therapy as an adjuvant treatment in postmenopausal patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.

Detailed Description

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

200Actual

Name	Type	Description	Arm Group Labels	Other Names
anastrozole	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients to be included in the program are that ones according to the indications specified in the Romanian anastrozole (Arimidex) approved SmPC (attached to the protocol)and who are already treated with anastrozole for at least 1 month before inclusion in this program/non-interventional study.

Exclusion Criteria:

Patients not to be included in the programme: patients who have a known hypersensitivity to anastrozole (Arimidex®) or any of its excipients.

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 patients with advanced breast cancer in whom a partial or complete response or stabilized disease were obtained with first line chemotherapy, by tumoral response assessment.

Sampling Method

Non-Probability Sample

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