Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Adebrelimab 1200mg i.v. q3w combined with nab-paclitaxel 100mg/m2 qw\*12w followed by epirubicin 90mg/m2 and cyclophosphamide 600mg/m2 q3w for 4 cycles
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGpCR rate
pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes
Time frame: up to 8 months, after patients complete surgery
ORR
Objective Response Rate: patients achieving partial response and complete response during treatment
Time frame: up to 8 months, after patients complete surgery
Incidence of adverse events (Safety)
adverse events of patients receiving at least one cycle of treatment
Time frame: up to 8 months, after patients complete surgery
pCR rate in PD-L1 CPS≥1 subgroup
pathological complete response rate in patients with PD-L1 CPS score ≥1
Time frame: up to 8 months, after patients complete surgery
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