At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 164 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 10mgfrom 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 Ib/II Randomized Study of BI 836845 in Combination With Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women With Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Everolimus, Exemestane, and 1 other intervention for Neoplasms. Completed, enrolled 164 participants across 38 sites in 10 countries.
Detailed Summary
Phase Ib / II study to determine the Maximum Tolerated Dose and Recommended Phase II Dose, and to evaluate the safety and antitumour activity, of BI 836845 and everolimus in combination with exemestane in women with HR+/HER2- advanced breast cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms
CountriesAustria, Belgium, France, Ireland, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartMay 2014
Primary CompletionNov 2016
Study CompletionDec 2021
TodayJul 2026
First PostedApr 28, 2014
Enrollment StartMay 15, 2014
Primary CompletionNov 25, 2016
Study CompletionDec 14, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.2 years ago
Interventions
Everolimusdrug
10mg dose
Exemestanedrug
Fixed dose at 25mg
BI 836845drug
1000 mg, recommended dose per Phase Ib part. Human monoclonal antibody. Dose escalation in Phase Ib. 2 dose levels (high or low) depending on the dose cohort explored