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NCT00878930 Clinical Trial

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

Breast Cancer Clinical Trial

— FRAME  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00878930
Other study ID # NIS-OAR-FAS-2008/1
Secondary ID
Status Completed
Phase N/A
First received April 8, 2009
Last updated January 4, 2011
Start date April 2009
Est. completion date December 2010

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Research Site Bahia Blanca Buenos Aires
Argentina Research Site Campana Buenos Aires
Argentina Research Site Ciudad de Buenos Aires Buenos Aires
Argentina Research Site Cordoba
Argentina Research Site La Plata Buenos Aires
Argentina Research Site Mar del Plata Buenos Aires
Argentina Research Site Mendoza
Argentina Research Site Moron Buenos Aires
Argentina Research Site Pergamino Buenos Aires
Argentina Research Site Rio Grande Tierra del Fuego
Argentina Research Site Rosario Santa Fe
Argentina Research Site San Martin Buenos Aires
Argentina Research Site Santa Rosa La Pampa
Argentina Research Site Tandil Buenos Aires
Argentina Research Site Tucuman
Argentina Research Site Vicente Lopez Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population. monthly No
Primary To collect real life data of efficacy on the use of Faslodex in the Argentine population. monthly No
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