At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 141 enrolled
Drug / intervention
Fulvestrant +1 moredrug
Likely dose
Not stated in 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.
An Open-Label Phase 2 Study of MLN0128 (A TORC1/2 Inhibitor) in Combination With Fulvestrant in Women With ER-Positive/HER2-Negative Advanced or Metastatic Breast Cancer That Has Progressed During or After Aromatase Inhibitor Therapy
In Brief
A Phase 2 clinical trial evaluating Fulvestrant and Sapanisertib for Breast Neoplasms. Completed, enrolled 141 participants across 53 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants treated with single-agent fulvestrant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesSpain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionNov 2019
TodayJul 2026
First PostedApr 29, 2016
Enrollment StartJul 28, 2016
Primary CompletionNov 25, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago
Interventions
Fulvestrantdrug
Fulvestrant IM injection.
Sapanisertibdrug
Sapanisertib capsule.