At a glance
ClinicalIndex Comparison RecordPhase 2Active· 61 enrolled
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
Enzalutamide 160mgfrom 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.
Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Enzalutamide and Fulvestrant for Breast Cancer. Active but no longer recruiting, targeting 61 participants across 3 sites.
Detailed Summary
This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after \~4 months on treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense
Timeline
Phase 2Active
20172018201920202021202220232024202520262027
First PostedNov 2016
Enrollment StartSep 2017
Primary CompletionFeb 2023
TodayJul 2026
Study CompletionFeb 2027
First PostedNov 4, 2016
Enrollment StartSep 21, 2017
Primary CompletionFeb 17, 2023
Study CompletionFeb 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.7 years ago
Interventions
Enzalutamidedrug
160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
Fulvestrantdrug
500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)