At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 462 enrolled
Drug / intervention
faslodex 500mg +3 moredrug
Likely dose
faslodex 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
In Brief
A Phase 3 clinical trial evaluating faslodex 500mg, arimidex 1mg, and 2 other interventions for Hormone Receptor Positive Breast Cancer. Completed, enrolled 462 participants across 118 sites in 20 countries.
Detailed Summary
The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone Receptor Positive Breast Cancer
CountriesArgentina, Brazil, Canada, China, Czechia, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartOct 2012
Primary CompletionApr 2016
Study CompletionJan 2026
TodayJul 2026
First PostedMay 21, 2012
Enrollment StartOct 17, 2012
Primary CompletionApr 11, 2016
Study CompletionJan 16, 2026
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.1 years ago
Interventions
faslodex 500mgdrug
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex 1mgdrug
oral tablet 1 daily
faslodex dummydrug
2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
arimidex dummydrug
oral tablet 1 daily