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Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660803
First Posted: April 17, 2008
Last Update Posted: January 21, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dendrix - Scientific Information Architecture
Information provided by:
AstraZeneca
  Purpose
Characterize the demographic and clinical features, as well as the main treatment results, among patients with advanced breast cancer treated with fulvestrant in Brazil.

Condition Intervention
Breast Cancer Drug: Fulvestrant

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to tumour progression
  • Objective response

Secondary Outcome Measures:
  • Duration of treatment with fulvestrant
  • Time and duration of response
  • Overall survival

Estimated Enrollment: 200
Study Start Date: May 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: Faslodex

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitals and primary care clinics
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660803


Locations
Brazil
Research Site
Recife, PE, Brazil
Research Site
Rio de Janeiro, RJ, Brazil
Research Site
Porto Alegre, RS, Brazil
Research Site
Sao Paulo, SP, Brazil
Sponsors and Collaborators
AstraZeneca
Dendrix - Scientific Information Architecture
  More Information

Responsible Party: Jose Eduardo Neves - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660803     History of Changes
Other Study ID Numbers: NIS-OBR-FAS-2007/1
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: January 21, 2010
Last Verified: January 2010

Keywords provided by AstraZeneca:
Advanced Breast Cancer
Hormone Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones