Study of Faslodex with or without concomitant Arimidex versus Exemestane following progression on Non-steroidal Aromatase Inhibitors (NSAI)
Study identifier:9238UK/0005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A partially-blind phase III randomised trial of Fulvestrant (Faslodex) with or without concomitant Anastrozole (Arimidex) compared with exemestane in postmenopausal women with ER+ve locally advanced/metastatic breast cancer following progression on non-steroidal aromatase inhibitors
Medical condition
Progression-free survival
Phase
Phase 3
Healthy volunteers
No
Study drug
fulvestrant, anastrozole, exemestane
Sex
Female
Actual Enrollment
25
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Dec 2008
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 fulvestrant and anastrozole | Drug: fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. Other Name: Faslodex Drug: anastrozole Tablet, oral, once daily until disease progression. Other Name: Arimidex |
| Experimental: 2 fulvestrant and placebo | Drug: fulvestrant Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression. Other Name: Faslodex |
| Active Comparator: 3 exemestane alone | Drug: exemestane Tablet, oral, once daily until disease progression. Other Name: Aromasin |
Contacts
Investigators
Principal Investigator
Young-Huck Im
Professor(Samsung Medical Center)
