Faslodex Observations During Regular Use by Advanced Mamm... | NCT00241462 | Trialant

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Faslodex Observations During Regular Use by Advanced Mamm... | NCT00241462 | Trialant

Studies
Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

NCT00241462

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Apr 22, 2009Estimated

Enrollment

150Estimated

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

NCT00241462

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

D6997-NL-001

Secondary IDs

ID	Type	Description	Link
FORUM

Brief Title

Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

Official Title

Faslodex Observations During Regular Use by Advanced Mammacarcinoma Patients

Acronym

FORUM

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to poor patient enrollment

Expanded Access Info

No

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Dec 2009Estimated

First Submitted Date

Oct 18, 2005

First Submission Date that Met QC Criteria

Oct 18, 2005

First Posted Date

Oct 19, 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

Apr 21, 2009

Last Update Posted Date

Apr 22, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

The purpose of this study is to identify which patients, receiving Faslodex within the approved label, benefit most from Faslodex treatment.

Detailed Description

Not provided

Conditions Module

Conditions

Breast Cancer

Keywords

Advanced Breast Cancer

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

150Estimated

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
Locally advanced or metastatic hormone sensitive breast cancer with known estrogen receptor (ER) and progesterone receptor (PR) status
Patient had a recurrence during or after adjuvant anti-oestrogen treatment or progression of the disease during anti-oestrogen treatment

Exclusion Criteria:

Life threatening metastases

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 Netherlands Medical Director, MD	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Alkmaar			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

Case-Only

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Almelo

Netherlands

Research Site

Almere Stad

Netherlands

Research Site

Amsterdam

Netherlands

Research Site

Apeldoorn

Netherlands

Research Site

Assen

Netherlands

Research Site

Bergen op Zoom

Netherlands

Research Site

Capelle aan den IJssel

Netherlands

Research Site

Delft

Netherlands

Research Site

Delfzijl

Netherlands

Research Site

Doetinchem

Netherlands

Research Site

Dokkum

Netherlands

Research Site

Dordrecht

Netherlands

Research Site

Drachten

Netherlands

Research Site

Ede Gld

Netherlands

Research Site

Eindhoven

Netherlands

Research Site

Geldrop

Netherlands

Research Site

Gorinchem

Netherlands

Research Site

Hardenberg

Netherlands

Research Site

Heerenveen

Netherlands

Research Site

Heerlen

Netherlands

Research Site

Hellevoetsluis

Netherlands

Research Site

Hilversum

Netherlands

Research Site

Hoogeveen

Netherlands

Research Site

Leiden

Netherlands

Research Site

Leiderdorp

Netherlands

Research Site

Leidschendam

Netherlands

Research Site

Meppel

Netherlands

Research Site

Nieuwegein

Netherlands

Research Site

Oss

Netherlands

Research Site

Roermond

Netherlands

Research Site

Rotterdam

Netherlands

Research Site

Stadskanaal

Netherlands

Research Site

Terneuzen

Netherlands

Research Site

The Hague

Netherlands

Research Site

Tilburg

Netherlands

Research Site

Utrecht

Netherlands

Research Site

Vlaardingen

Netherlands

Research Site

Winschoten

Netherlands

Research Site

Winterswijk

Netherlands

Research Site

Zeist

Netherlands

Research Site

Zevenaar

Netherlands

Research Site

Zwolle

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