Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

This study has been completed.
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Information provided by:
AstraZeneca Identifier:
First received: April 15, 2008
Last updated: January 20, 2010
Last verified: January 2010
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 [ Designated as safety issue: No ]
  • Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of treatment with fulvestrant [ Designated as safety issue: No ]
  • Time and duration of response [ Designated as safety issue: No ]
  • 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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hospitals and primary care clinics

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
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Please refer to this study by its identifier: NCT00660803

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
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  More Information

No publications provided

Responsible Party: Jose Eduardo Neves - Medical Science Director, AstraZeneca Identifier: NCT00660803     History of Changes
Other Study ID Numbers: NIS-OBR-FAS-2007/1
Study First Received: April 15, 2008
Last Updated: January 20, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Health Surveillance Agency

Keywords provided by AstraZeneca:
Advanced Breast Cancer
Hormone Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on December 01, 2015