This is a prospective, open-label, phase II, multicenter exploratory clinical study. Eligible female patients aged 18-75 years with stage II-III HER2-positive breast cancer will receive 4 cycles of SHR-A1811 (4.8 mg/kg, intravenous infusion every 3 weeks). After 4 cycles, tumor response will be assessed per RECIST 1.1 criteria. Patients with a ≥50% reduction in tumor burden will continue with another 4 cycles of SHR-A1811 followed by definitive surgery. Patients with \<50% reduction will receive 4 cycles of the THPy regimen (docetaxel + trastuzumab + pyrotinib) before surgery. Circulating tumor DNA (ctDNA) will be assessed for minimal residual disease (MRD) at baseline, after 4 cycles of treatment, and postoperatively. The primary endpoint is total pathological complete response (tpCR), assessed by an independent review committee (IRC). This study aims to evaluate the efficacy, safety, and feasibility of imaging- and MRD-guided neoadjuvant therapy in HER2-positive breast cancer.
Female aged ≥18 years and ≤75 years.
Histopathologically confirmed invasive breast cancer with no prior systemic anti-tumor therapy for breast cancer.
Histopathologically confirmed HER2-positive status in accordance with the 2018 ASCO-CAP HER2 testing guideline criteria: immunohistochemistry (IHC) score of 3+, or IHC 2+ with positive in situ hybridization (ISH) test (ISH amplification ratio ≥2.0); hormone receptor status must be available.
Stage II-III breast cancer per the 8th edition AJCC Breast Cancer Staging System.
Stage IV breast cancer.
Inflammatory breast cancer.
Prior anti-tumor therapy or radiotherapy for any malignancy, or concurrent other malignant tumors, except cured carcinoma in situ of cervix, basal cell carcinoma or squamous cell carcinoma.
Concurrent receipt of anti-tumor therapy in another clinical trial, including but not limited to chemotherapy, endocrine therapy, biotherapy, bone-modifying agent therapy or immune checkpoint inhibitor therapy.
Single group
SHR-A1811
DrugSHR-A1811, 4.8 mg/kg, intravenous infusion once every 3 weeks. All patients receive initial 4 cycles; responders continue additional 4 cycles before surgery.
THPy
DrugCombined regimen of docetaxel, trastuzumab, and pyrotinib. Administered for 4 cycles to patients with insufficient tumor response after the initial 4 cycles of SHR-A1811 prior to definitive surgery.
Rate of total pathological complete response (tpCR)
Rate of breast pathological complete response (bpCR)
Objective Response Rate (ORR)
Incidence and severity of Adverse Events (AEs)
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