A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer
Female
Advanced Breast Cancer
Trial Information
A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Inclusion Criteria:
- Postmenopausal advanced breast cancer with oestrogen receptor positive
- Progression under first-line anti-oestrogen therapy.
Exclusion Criteria:
- Life-threatening metastasis; contraindication to anastrozole
- >2 regimens of hormonotherapy for advanced breast cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to Disease Progression (TTP)
Principal Investigator
Breast Cancer Established Brands Team Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
China: Food and Drug Administration
Study ID:
D6997L00004
NCT ID:
NCT00327769
Start Date:
November 2005
Completion Date:
September 2007
Related Keywords:
- Advanced Breast Cancer
- Advanced breast cancer
- fulvestrant
- anastrozole
- Breast Neoplasms
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