Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer (FRAME)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00878930
First received: April 8, 2009
Last updated: January 4, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
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) |
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
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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 19, 2013