Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
NCT ID: NCT00944918
Last Updated: 2011-08-29
Study Results
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Basic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2008-12-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
fulvestrant and anastrozole
fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
anastrozole
Tablet, oral, once daily until disease progression.
2
fulvestrant and placebo
fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
3
exemestane alone
exemestane
Tablet, oral, once daily until disease progression.
Interventions
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fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
anastrozole
Tablet, oral, once daily until disease progression.
exemestane
Tablet, oral, once daily until disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic disease must be measurable or evaluable
* Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
* NSAI given as adjuvant therapy that lasted ≥ 12 months OR
* Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
* Female postmenopausal patients
Exclusion Criteria
* Prescribed Tamoxifen for metastatic disease
* Rapidly progressive visceral disease
* Patients with malignancies within the last 5 years.
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Young-Huck Im
Role: PRINCIPAL_INVESTIGATOR
Professor(Samsung Medical Center)
Locations
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Research Site
Ilsan, , South Korea
Research Site
Seoul, , South Korea
Countries
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References
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Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.
Other Identifiers
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9238UK/0005
Identifier Type: -
Identifier Source: org_study_id
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