A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
FIRST
A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
2 other identifiers
interventional
205
9 countries
41
Brief Summary
The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2006
Longer than P75 for phase_2
41 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
First Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedStudy Start
First participant enrolled
February 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2008
CompletedResults Posted
Study results publicly available
August 12, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2017
CompletedSeptember 6, 2019
August 1, 2019
1.9 years
January 10, 2006
January 27, 2009
August 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) for at least 24 weeks evaluated according to modified RECIST. The Clinical Benefit Rate is the percentage of patients with CB.
From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Secondary Outcomes (4)
Objective Response Rate
From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Progression
From randomisation to data cut off (DCO) for primary analysis. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007 respectively. The DCO for primary analysis was on 10th Jan 2008, 6 months after the last patient was enrolled.
Time to Treatment Failure
From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Time to Progression (Investigator Assessed)
From randomisation to data cut off (DCO) for 75% treatment failure. The first and the last patients were enrolled on 6 Feb 2006 and 11 Jul 2007. The DCO for 75% treatment failure was on 26 Mar 2010, 32 months after the last patient was enrolled.
Study Arms (2)
1
EXPERIMENTALFulvestrant
2
ACTIVE COMPARATORAnastrozole
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed hormone receptor positive advanced breast cancer, postmenopausal women
You may not qualify if:
- Previous treatment for advanced breast cancer (previous treatment for early breast cancer is allowed).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (41)
Research Site
Frederick, Maryland, 21701, United States
Research Site
St Louis, Missouri, 63113, United States
Research Site
Teaneck, New Jersey, 07666, United States
Research Site
Austin, Texas, 78705, United States
Research Site
Duncanville, Texas, 75137, United States
Research Site
Barretos, 14784-400, Brazil
Research Site
Belo Horizonte, 30380-490, Brazil
Research Site
Goiânia, 74000-000, Brazil
Research Site
Jaú, 17210-120, Brazil
Research Site
Rio de Janeiro, 20560-120, Brazil
Research Site
São Paulo, 01219-010, Brazil
Research Site
Blagoevgrad, 2700, Bulgaria
Research Site
Plovdiv, 4000, Bulgaria
Research Site
Shumen, 9700, Bulgaria
Research Site
Sofia, 1233, Bulgaria
Research Site
Sofia, 1527, Bulgaria
Research Site
Sofia, 1784, Bulgaria
Research Site
Varna, 9000, Bulgaria
Research Site
Veliko Tarnovo, 5000, Bulgaria
Research Site
Vratsa, 3000, Bulgaria
Research Site
Brno, 656 53, Czechia
Research Site
Brno, 656 91, Czechia
Research Site
Jičín, 506 43, Czechia
Research Site
Ostrava, 708 52, Czechia
Research Site
Prague, 140 00, Czechia
Research Site
Ústí nad Labem, 401 13, Czechia
Research Site
Nice, 06100, France
Research Site
Poitiers, 86000, France
Research Site
Saint-Cloud, 92210, France
Research Site
Napoli, 80131, Italy
Research Site
Sassari, 07100, Italy
Research Site
Krakow, 31-115, Poland
Research Site
Olsztyn, 10-228, Poland
Research Site
Barcelona, 08003, Spain
Research Site
Barcelona, 08025, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Lleida, 25198, Spain
Research Site
Pontevedra, 36002, Spain
Research Site
Derby, DE22 3DT, United Kingdom
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
Edinburgh, EH4 2XU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
One patient in the ITT population was randomized to Fulvestrant 500 but did not receive drug and was excluded from the safety population. Hence, the safety population for Fulvestrant contained 101 patients.
Results Point of Contact
- Title
- Jasmine Lichfield
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Faslodex Medical Science Director, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
February 6, 2006
Primary Completion
January 10, 2008
Study Completion
January 13, 2017
Last Updated
September 6, 2019
Results First Posted
August 12, 2009
Record last verified: 2019-08