Adults 18 to 99, female only, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) - Phase II PartPrimary· From randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause or data cut-off (25Nov2016), up to 30 months.
Progression-free survival (PFS) in the phase II part is presented. Progression-free survival (PFS) was defined as the time from randomisation until radiological tumour progression according to RECIST 1.1, or death from any cause, whichever occurred earlier. Clinical disease progression was not considered for determination of a PFS event, unless the outcome of the progression was death. The cut-off date was 25th November 2016. At cut-off date, xentuzumab was discontinued in all patients in the experimental arm per sponsor decision, recruitment was also terminated. Patients who discontinued xent
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
7.3
3.3 – NA
Everolimus 10 mg + Exemestane 25 mg - Phase II
5.6
3.7 – 9.1
Number of Patients With Dose Limiting Toxicity (DLT) - Phase Ib PartPrimary· From first administration of study treatment until end of first treatment cycle, up to 28 days.
Number of patients with dose limiting toxicity (DLT) in phase Ib part is presented.
Maximum Tolerated Dose (MTD) - Phase Ib PartPrimary· up to 28 days.
The Maximum Tolerated Dose (MTD) in this study was defined as the highest dose level examined of trial medication, at which no more than 1 out of 6 patients experienced a DLT during the MTD evaluation period.
The MTD evaluation period was defined as the time from the first administration of xentuzumab up to start of cycle 2.
A "3+3" Phase Ib dose finding phase was performed to determine the MTD.
Group
Value
95% CI
Xentuzumab (BI 836845)
1000
Number of Patients With Objective Response (OR) - Phase II PartSecondary· From randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy or data cut-off (25Nov2016), up to 30 months.
Objective response (OR) - phase II part is presented. Objective response (OR), defined as best overall response of complete response (CR) or partial response (PR), where best overall response was determined according to RECIST 1.1 from date of randomisation until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy.
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
5
2.4 – 15.9
Everolimus 10 mg + Exemestane 25 mg - Phase II
7
4.1 – 19.5
Time to Progression (TTP) - Phase II PartSecondary· From randomisation until the date of the first objective tumour progression according to RECIST 1.1. or data cut-off (25Nov2016), up to 30 months.
Time to progression (TTP) is presented. Time to progression (TTP), defined as the time from the date of randomization until the date of the first objective tumour progression according to RECIST 1.1.
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
7.3
3.7 – NA
Everolimus 10 mg + Exemestane 25 mg - Phase II
5.6
5.3 – 9.1
Number of Patients With Disease Control (DC) - Phase II PartSecondary· From randomisation until data cut-off (25Nov2016), up to 30 months.
Disease control is defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) \>= 24 weeks, or Non-CR/Non-PD for \>= 24 weeks. PD=Progressive disease.
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
13
10.3 – 29.7
Everolimus 10 mg + Exemestane 25 mg - Phase II
17
14.8 – 36.0
Time to Objective Response - Phase II PartSecondary· From randomisation until first documented complete response (CR) or partial response (PR) or data cut-off (25Nov2016), up to 30 months.
Time to objective response is presented. Time to objective response is defined as the time from randomisation until first documented complete response (CR) or partial response (PR).
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
3.7
3.6 – 5.3
Everolimus 10 mg + Exemestane 25 mg - Phase II
1.8
1.7 – 5.3
Duration of Objective Response - Phase II PartSecondary· From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.
Duration of objective response is presented. Duration of objective response is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response (OR).
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
5.6
5.6 – 5.6
Everolimus 10 mg + Exemestane 25 mg - Phase II
NA
NA – NA
Duration of Disease Control - Phase II PartSecondary· From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.
Duration of disease control is presented. Duration of disease control is defined as the time from randomisation until the earliest of disease progression or death, among patients with disease control.
Group
Value
95% CI
Xentuzumab (BI 836845) 1000 mg + Everolimus 10 mg + Exemestane 25 mg - Phase II
NA
10.9 – NA
Everolimus 10 mg + Exemestane 25 mg - Phase II
9.3
9.1 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: For all AEs including all-cause mortality: Phase Ib: from first dose until last dose + 42 days of residual effect period, up to 54.3 months + 42 days Phase II: from first dose until last dose + 42 days of residual effect period, up to 37.7 months + 42 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy
· EARLY_PHASE1
· recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
· Phase 1
· not yet recruiting
NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
· Phase 2
· not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
· Phase 3
· recruiting
NCT06832189 — EVR and EPO for Liver Transplant Tolerance
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 15 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02123823.