Faslodex Advanced Breast Cancer Local Chinese Study
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
1 other identifier
interventional
234
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2005
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 18, 2006
CompletedFirst Posted
Study publicly available on registry
May 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 25, 2011
January 1, 2011
May 18, 2006
January 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Disease Progression (TTP)
Secondary Outcomes (4)
Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Time to Treatment Failure (TTF)
Safety & Tolerability.
Study Arms (2)
1
ACTIVE COMPARATORAnastrozole
2
EXPERIMENTALAnastrozole + Fulvestrant
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal advanced breast cancer with oestrogen receptor positive
- Progression under first-line anti-oestrogen therapy.
You may not qualify if:
- Life-threatening metastasis; contraindication to anastrozole
- \>2 regimens of hormonotherapy for advanced breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Beijing, China
Research Site
Dalian, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hankou, China
Research Site
Hefei, China
Research Site
Huangzhou, China
Research Site
Jinan, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Wuhan, China
Research Site
Xi'an, China
Related Publications (1)
Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.
PMID: 20938664DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Breast Cancer Established Brands Team Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 18, 2006
First Posted
May 19, 2006
Study Start
November 1, 2005
Study Completion
September 1, 2007
Last Updated
January 25, 2011
Record last verified: 2011-01