Retrospective Brazilian Study of Fulvestrant in Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Dendrix - Scientific Information Architecture
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660803
First received: April 15, 2008
Last updated: January 20, 2010
Last verified: January 2010
  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 [ 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
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on July 29, 2014