This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.
The cure rate of stage I and II triple-negative breast cancer treated with anthracycline-based chemotherapy is high but comes at the price of substantial toxicity. This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate and immune effects of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
I.V Pembrolizumab (keytruda) 200 mg every 3 weeks for 6 cycles
I.V Carboplatin at AUC 1.5 weekly for a total of 12 weeks.
I.V Paclitaxel at 80 mg/m2 weekly for a total of 12 weeks.
Pathological complete response rate (pCR= ypT0/Tis ypN0)
The number of patients with pathological complete response (pCR) out of the total number of trial participants using a definition of ypT0/Tis ypN0 after treatment with neoadjuvant pembrolizumab, paclitaxel and carboplatin (PCb).
Time frame: 3 years
Molecular dynamics of cells in the tumor microenvironment (TME)
The molecular state of cells in the TME will be measured at a single-cell level using single-cell RNA sequencing (scRNA-seq) before and after one dose of pembrolizumab.
Time frame: 3 years
3-year overall survival (OS) rate
The number of patients that are alive three years after entering the trial out of the total number of trial participants.
Time frame: 5 years
3-year event-free survival (EFS) rate
The number of patients without disease recurrence three years after entering the trial out of the total number of trial participants.
Time frame: 5 years
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