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
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sandra Mercurio / Medical Director, AZ Argentina
ClinicalTrials.gov Identifier: NCT00878930     History of Changes
Other Study ID Numbers: NIS-OAR-FAS-2008/1
Study First Received: April 8, 2009
Last Updated: January 4, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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

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

ClinicalTrials.gov processed this record on October 29, 2014