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Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681369
First received: May 20, 2008
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

Resource links provided by NLM:

Drug Information available for: Fulvestrant
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Evaluate Faslodex therapeutic strategy and treatment duration [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Describe the characteristics of patients treated with Faslodex [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: May 2007
Study Completion Date: June 2007
Groups/Cohorts
1
Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospital sample

Criteria

Inclusion Criteria:

  • Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681369

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Alain FLINOIS TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge
  More Information

No publications provided

Responsible Party: Francisco Sapunar - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00681369     History of Changes
Other Study ID Numbers: NIS-OFR-FAS-2007/1
Study First Received: May 20, 2008
Last Updated: January 21, 2011
Health Authority: France: Haute Autorité de Santé Transparency Commission

Keywords provided by AstraZeneca:
breast cancer
fulvestrant
longitudinal study
France

Additional relevant MeSH terms:
Breast Neoplasms
Stress, Psychological
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Fulvestrant
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

ClinicalTrials.gov processed this record on May 16, 2013