Retrospective Brazilian Study of Fulvestrant in Advanced... | NCT00660803

Studies
Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

NCT00660803

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jan 21, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Fulvestrant

Countries

Brazil

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

Jan 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

May 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 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

Jan 20, 2010

Last Update Posted Date

Jan 21, 2010Estimated

Name	Class
Dendrix - Scientific Information Architecture	UNKNOWN

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

Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Postmenopausal women with hormone-receptor positive, advanced breast cancer who have failed at least one previous endocrine therapy and who have been treated at any one of the participating centres with fulvestrant.	Drug: Fulvestrant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fulvestrant	Drug		1	Faslodex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to tumour progression
Objective response

Secondary Outcomes

Measure	Description	Time Frame
Duration of treatment with fulvestrant
Time and duration of response
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive HR or ER by immunohistochemistry
Postmenopausal status at the time of treatment with fulvestrant
Failure of at least one previous endocrine therapy before treatment with fulvestrant.

Exclusion Criteria:

Patients who are still undergoing treatment with fulvestrant will not be eligible to participate in the study

Accepts Healthy Volunteers

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

hospitals and primary care clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Recife	Pernambuco		Brazil
Research Site

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

Intervention Browse Module

MeSH Terms

ID	Term
D000077267	Fulvestrant

Ancestor Terms

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided