Status:
COMPLETED
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
Lead Sponsor:
AstraZeneca
Conditions:
Progression-free Survival
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the breast.
- 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
- Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
- Prescribed Tamoxifen for metastatic disease
- Rapidly progressive visceral disease
- Patients with malignancies within the last 5 years.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00944918
Start Date
December 1 2008
End Date
June 1 2011
Last Update
August 29 2011
Active Locations (2)
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1
Research Site
Ilsan, South Korea
2
Research Site
Seoul, South Korea