HR-negative/HER2-negative resectable stage I TNBC.
Conditions
Brief summary
The efficacy will be evaluated by pCR rates concerning breast and lymph nodes (pCRBREAST+LYMPH NODE) in the overall population. pCR is defined as the absence of invasive carcinoma in both breast and lymph node tissue following completion of neoadjuvant treatment. The pCR rate will be calculated as the number of responders divided by the number of patients in the analysis set per 100.
Detailed description
pCR rates will be calculated concerning breast and lymph nodes (pCRBREAST+LYMPH NODE) in patients with PD-L1 (+) tumors., RCB score and BCS rate in the overall population at surgery, Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) based on local Investigator assessment as per NCI-CTCAE v5.0.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Medica Scientia Innovation Research S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy will be evaluated by pCR rates concerning breast and lymph nodes (pCRBREAST+LYMPH NODE) in the overall population. pCR is defined as the absence of invasive carcinoma in both breast and lymph node tissue following completion of neoadjuvant treatment. The pCR rate will be calculated as the number of responders divided by the number of patients in the analysis set per 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rates will be calculated concerning breast and lymph nodes (pCRBREAST+LYMPH NODE) in patients with PD-L1 (+) tumors., RCB score and BCS rate in the overall population at surgery, Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) based on local Investigator assessment as per NCI-CTCAE v5.0. | — |
Countries
Spain
Outcome results
None listed