NCT00327769
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Anastrozole
- Conditions
- Advanced Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Time to Disease Progression (TTP)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.
Investigators
Eligibility Criteria
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
Arms & Interventions
2
Anastrozole + Fulvestrant
Intervention: Anastrozole
1
Anastrozole
Intervention: Anastrozole
2
Anastrozole + Fulvestrant
Intervention: Fulvestrant
Outcomes
Primary Outcomes
Time to Disease Progression (TTP)
Secondary Outcomes
- Safety & Tolerability.
- Clinical Benefit Rate (CBR)
- Objective Response Rate (ORR)
- Time to Treatment Failure (TTF)
Study Sites (1)
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