At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 514 enrolled
Drug / intervention
Fulvestrant +1 moredrug
Likely dose
Fulvestrant 250 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.
FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
In Brief
A Phase 3 clinical trial evaluating Fulvestrant and Anastrozole for Breast Cancer. Completed, enrolled 514 participants across 85 sites in 12 countries.
Detailed Summary
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Costa Rica, Finland, France, Germany, Guatemala, Iceland, Italy, Norway, Portugal, Sweden, Turkey (Türkiye)
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
First PostedNov 2005
Primary CompletionApr 2009
Study CompletionFeb 2012
TodayJul 2026
First PostedNov 22, 2005
Enrollment StartJan 1, 2004
Primary CompletionApr 1, 2009
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.6 years ago
Interventions
Fulvestrantdrug
intramuscular injection 250 mg loading dose (LD) regimen
Anastrozoledrug
1 mg oral tablet