At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 118 enrolled
Drug / intervention
Sapanisertib +2 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.
A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant
In Brief
A Phase 2 clinical trial evaluating Sapanisertib, Fulvestrant, and 1 other intervention for Breast Cancer. Completed, enrolled 118 participants across 40 sites in 3 countries.
Detailed Summary
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesBelgium, France, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartFeb 2014
Primary CompletionJun 2018
TodayJul 2026
First PostedJan 30, 2014
Enrollment StartFeb 13, 2014
Primary CompletionJun 29, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.4 years ago
Interventions
Sapanisertibdrug
Sapnisertib capsules
Fulvestrantdrug
Fulvestrant IM injection.
Exemestanedrug
Exemestane tablets.