- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878930
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer (FRAME)
January 4, 2011 updated by: AstraZeneca
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cordoba, Argentina
- Research Site
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Mendoza, Argentina
- Research Site
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Tucuman, Argentina
- Research Site
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Buenos Aires
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Bahia Blanca, Buenos Aires, Argentina
- Research Site
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Campana, Buenos Aires, Argentina
- Research Site
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Ciudad de Buenos Aires, Buenos Aires, Argentina
- Research Site
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La Plata, Buenos Aires, Argentina
- Research Site
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Mar del Plata, Buenos Aires, Argentina
- Research Site
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Moron, Buenos Aires, Argentina
- Research Site
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Pergamino, Buenos Aires, Argentina
- Research Site
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San Martin, Buenos Aires, Argentina
- Research Site
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Tandil, Buenos Aires, Argentina
- Research Site
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Vicente Lopez, Buenos Aires, Argentina
- Research Site
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La Pampa
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Santa Rosa, La Pampa, Argentina
- Research Site
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Santa Fe
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Rosario, Santa Fe, Argentina
- Research Site
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Tierra del Fuego
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Rio Grande, Tierra del Fuego, Argentina
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Post-menopausal women with advanced breast cancer hormone receptor-positive who have progressed to a one prior hormone therapy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population.
Time Frame: monthly
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monthly
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To collect real life data of efficacy on the use of Faslodex in the Argentine population.
Time Frame: monthly
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monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 8, 2009
First Submitted That Met QC Criteria
April 8, 2009
First Posted (Estimate)
April 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 5, 2011
Last Update Submitted That Met QC Criteria
January 4, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-OAR-FAS-2008/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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