At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Everolimus 5 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 Phase II Study of Combined Fulvestrant (Faslodex) and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure
In Brief
A Phase 2 clinical trial evaluating Everolimus and Fulvestrant for Breast Cancer. Completed, enrolled 33 participants across 1 site.
Detailed Summary
The primary objective of this study is to determine if estrogen receptor-targeted therapy with fulvestrant used in combination with Everolimus is an effective and safe therapy for women with hormone receptor positive metastatic breast cancer after failure of aromatase inhibitor therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNovartis
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2007
Enrollment StartApr 2008
Primary CompletionFeb 2013
Study CompletionJan 2015
TodayJul 2026
First PostedDec 11, 2007
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2013
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.6 years ago
Interventions
Everolimusdrug
Everolimus tablets, two-5 mg tablets a day
Fulvestrantdrug
intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter