At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
Ribociclib +2 moredrug
Likely dose
Ribociclib 50 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 I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor
In Brief
A Phase 2 clinical trial evaluating Ribociclib, Everolimus, and 1 other intervention for Breast Cancer. Completed, enrolled 104 participants across 25 sites.
Detailed Summary
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionFeb 2020
TodayJul 2026
First PostedApr 8, 2016
Enrollment StartJun 14, 2016
Primary CompletionFeb 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 10.2 years ago
Interventions
Ribociclibdrug
supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
Everolimusdrug
supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
Exemestanedrug
supplied in 25 mg tablets taken orally, daily for 28 day cycle