Early stage triple negative breast cancer
Conditions
Brief summary
Pathological complete response (pCR breast and nodes) as defined by ypT0/Tis/ypN0
Detailed description
Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the higher TIL subgroup (%TIL on baseline H&E 30% or more), Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the PD-L1 positive subgroup (defined as 1% or more immune cell staining using the Ventana SP142 assay), Pathological complete response (pCR) in breast (ypT0/Tis), Residual cancer burden (RCB)0/1, Tumour response by WHO Criteria, Ki67 proliferation marker changes between baseline and surgery, Safety and tolerability as documented according to NCI-CTCAE V5.0, Event free survival and overall survival over a 3-year period
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
ANZ Breast Cancer Trials Group Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR breast and nodes) as defined by ypT0/Tis/ypN0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the higher TIL subgroup (%TIL on baseline H&E 30% or more), Pathological complete response (pCR as defined by ypT0/Tis/ypN0) in the PD-L1 positive subgroup (defined as 1% or more immune cell staining using the Ventana SP142 assay), Pathological complete response (pCR) in breast (ypT0/Tis), Residual cancer burden (RCB)0/1, Tumour response by WHO Criteria, Ki67 proliferation marker changes between baseline and surgery, Safety and tolerability as documented according to NCI-CTCAE V5.0, Event free survival and overall survival over a 3-year period | — |
Countries
Italy
Outcome results
None listed