At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
Fulvestrant with Enzalutamidedrug
Likely dose
Fulvestrant with Enzalutamide 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.
Phase II Trial of Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Fulvestrant with Enzalutamide for Breast Cancer. Completed, enrolled 32 participants across 3 sites.
Detailed Summary
A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and Her2 normal.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsUnited States Department of Defense
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartJul 2017
Primary CompletionNov 2019
Study CompletionApr 2020
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartJul 6, 2017
Primary CompletionNov 21, 2019
Study CompletionApr 10, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.7 years ago
Interventions
Fulvestrant with Enzalutamidedrug
500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.