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

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ClinicalTrials.gov Identifier: NCT00878930
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : January 5, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief 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.

Condition or disease
Breast Cancer

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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant
U.S. FDA Resources




Primary Outcome Measures :
  1. To collect real life data of acceptability and compliance on the use of Faslodex in the Argentine population. [ Time Frame: monthly ]
  2. To collect real life data of efficacy on the use of Faslodex in the Argentine population. [ Time Frame: monthly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878930


Locations
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
La Plata, Buenos Aires, Argentina
Research Site
Mar del Plata, Buenos Aires, Argentina
Research Site
Moron, Buenos Aires, Argentina
Research Site
Pergamino, Buenos Aires, Argentina
Research Site
San Martin, Buenos Aires, Argentina
Research Site
Tandil, Buenos Aires, Argentina
Research Site
Vicente Lopez, Buenos Aires, Argentina
Research Site
Santa Rosa, La Pampa, Argentina
Research Site
Rosario, Santa Fe, Argentina
Research Site
Rio Grande, Tierra del Fuego, Argentina
Research Site
Cordoba, Argentina
Research Site
Mendoza, Argentina
Research Site
Tucuman, Argentina
Sponsors and Collaborators
AstraZeneca

Responsible Party: Sandra Mercurio / Medical Director, AZ Argentina
ClinicalTrials.gov Identifier: NCT00878930     History of Changes
Other Study ID Numbers: NIS-OAR-FAS-2008/1
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Breast cancer
Fulvestrant
Faslodex
Acceptability
Compliance
Efficacy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs