At a glance
ClinicalIndex Comparison RecordPhase 3Active· 736 enrolled / 736 target
Drug / intervention
Fulvestrantdrug
Likely dose
500 mgfrom 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 Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
In Brief
A Phase 3 clinical trial evaluating Fulvestrant for Breast Cancer. Active but no longer recruiting, targeting 736 participants across 106 sites in 17 countries.
Signals
Enrollment appears stalled
Detailed Summary
The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBelgium, Brazil, Chile, Colombia, Czechia, Hungary, India, Italy, Malta, Mexico, Poland, Russia, Slovakia, Spain, Ukraine, United States, Venezuela
Collaborators--
Timeline
Phase 3Active
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2004
Enrollment StartFeb 2005
Primary CompletionFeb 2009
TodayJul 2026
Study CompletionDec 2026
First PostedDec 14, 2004
Enrollment StartFeb 13, 2005
Primary CompletionFeb 27, 2009
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 21.6 years ago
Arms & Interventions
1experimental
Fulvestrant 500 mg
Drug: Fulvestrant
2experimental
Fulvestrant 250 mg
Drug: Fulvestrant
Interventions
Fulvestrantdrug
intramuscular injection