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Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer (FRAME)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00878930
First received: April 8, 2009
Last updated: January 4, 2011
Last verified: January 2011

April 8, 2009
January 4, 2011
April 2009
December 2010   (final data collection date for primary outcome measure)
  • To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population. [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • To collect real life data of efficacy on the use of Faslodex in the Argentine population. [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00878930 on ClinicalTrials.gov Archive Site
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Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer
Non-interventional Report on Parameters of Acceptability, Efficacy and Compliance of Fulvestrant in Post-menopausal Patients With Advanced Breast Cancer HR Positive Who Progresses to One Prior Endocrine Therapy With Antiestrogens

The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.

In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.

Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
  • Signature of the informed consent

Exclusion Criteria:

  • Any contraindication to Faslodex administration
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT00878930
NIS-OAR-FAS-2008/1
No
Sandra Mercurio / Medical Director, AZ Argentina
AstraZeneca
Not Provided
Not Provided
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP