Status:
COMPLETED
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Breast Cancer
Metastatic Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor posit...
Eligibility Criteria
Inclusion
- Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Exclusion
- Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00305448
Start Date
March 1 2006
End Date
February 1 2012
Last Update
February 15 2012
Active Locations (35)
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1
Research Site
Nagoya, Aichi-ken, Japan
2
Research Site
Asahi, Chiba, Japan
3
Research Site
Chiba, Chiba, Japan
4
Research Site
Matsuyama, Ehime, Japan