NCT00660803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 21, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

April 15, 2008

Last Update Submit

January 20, 2010

Conditions

Breast Cancer

Keywords

Advanced Breast CancerHormone Therapy

Outcome Measures

Primary Outcomes (2)

  • Time to tumour progression

  • Objective response

Secondary Outcomes (3)

  • Duration of treatment with fulvestrant

  • Time and duration of response

  • Overall survival

Study Arms (1)

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

FulvestrantDRUG
Also known as: Faslodex
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospitals and primary care clinics

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Recife, Pernambuco, Brazil

Location

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Research Site

Porto Alegre, Rio Grande do Sul, Brazil

Location

Research Site

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 21, 2010

Record last verified: 2010-01

Locations

BR(4)