At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Ribociclib +3 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 Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
In Brief
A Phase 2 clinical trial evaluating Ribociclib, T-DM1, and 2 other interventions for Breast Cancer. Completed, enrolled 25 participants across 2 sites.
Detailed Summary
Participants that have breast cancer that has spread to other parts of the body, is positive for a protein called HER2, and has not responded to standard treatment. This research study is a way of gaining new knowledge about the combination of Ribociclib with other drugs as a possible treatment for this diagnosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNovartis
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMar 2016
Primary CompletionAug 2020
Study CompletionJun 2022
TodayJul 2026
First PostedJan 15, 2016
Enrollment StartMar 9, 2016
Primary CompletionAug 27, 2020
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.5 years ago
Interventions
Ribociclibdrug
T-DM1drug
Trastuzumabdrug
Fulvestrantdrug