advanced TNBC, eg. irresectable recurrent disease or metastatic disease
Conditions
Brief summary
Progression-free survival rate as measured by the proportion of patients free of progression after 12-weeks of treatment (PFS: time from administration of first treatment to tumor progression or death from any cause) according to RECIST1.1, Adverse events as measured according to CTCAE v5.0 and immune-related toxicity
Detailed description
Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1, Clinical benefit as measured by the clinical benefit rate (CBR) according to iRECIST and RECIST1.1, PFS measured by time to event, Overall survival (OS: time from therapy initiation to death from any cause)
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGTiragolumab
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate as measured by the proportion of patients free of progression after 12-weeks of treatment (PFS: time from administration of first treatment to tumor progression or death from any cause) according to RECIST1.1, Adverse events as measured according to CTCAE v5.0 and immune-related toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1, Clinical benefit as measured by the clinical benefit rate (CBR) according to iRECIST and RECIST1.1, PFS measured by time to event, Overall survival (OS: time from therapy initiation to death from any cause) | — |
Countries
Netherlands
Outcome results
None listed