A Phase 2 interventional study of Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide in Breast Cancer, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 48 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Adebrelimab 1200 mg Q3W combined with nab-paclitaxel (100 mg/m2 Q1W) for 4 cycles followed by epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) Q3W for 4 cycles.
Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
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
pCR 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
Plan to share: No
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Shanghai Jiao Tong University School of Medicine