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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
10mg dose
Fixed dose at 25mg
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
Progression-free Survival (PFS) - Phase II Part
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 xentuzumab treatment continued with everolimus 10 mg + exemestane 25 mg treatment.
Time frame: 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.
Number of Patients With Dose Limiting Toxicity (DLT) - Phase Ib Part
Number of patients with dose limiting toxicity (DLT) in phase Ib part is presented.
Time frame: From first administration of study treatment until end of first treatment cycle, up to 28 days.
Maximum Tolerated Dose (MTD) - Phase Ib Part
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.
Time frame: up to 28 days.
Number of Patients With Objective Response (OR) - Phase II Part
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.
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Medical University of Graz State Hospital - University Hospital Graz
Graz, Austria
Wilhelminenspital
Vienna, Austria
Brussels - UNIV UZ Brussel
Brussels, Belgium
Brussels - UNIV Saint-Luc
Brussels, Belgium
Charleroi - HOSP Grand Hôpital de Charleroi
Charleroi, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Liège - HOSP St-Joseph
Liège, Belgium
CHU UCL Namur - Site De Sainte-Elisabeth
Namur, Belgium
...and 28 more locations
Time frame: 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.
Time to Progression (TTP) - Phase II Part
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.
Time frame: 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.
Number of Patients With Disease Control (DC) - Phase II Part
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.
Time frame: From randomisation until data cut-off (25Nov2016), up to 30 months.
Time to Objective Response - Phase II Part
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).
Time frame: From randomisation until first documented complete response (CR) or partial response (PR) or data cut-off (25Nov2016), up to 30 months.
Duration of Objective Response - Phase II Part
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).
Time frame: From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.
Duration of Disease Control - Phase II Part
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.
Time frame: From randomisation until the earliest of disease progression or death or data cut-off (25Nov2016), up to 30 months.