The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
Female patients aged 18-75 years.
Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3.
Histopathologically confirmed ER-positive/HER2-negative, PR < 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Female patients during pregnancy or lactation.
Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
Has an active autoimmune disease that has received systemic treatment in the last 2 years.
Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
Single group
HIFU
Procedure/SurgeryHIFU therapy is administered to the targeted breast lesion site.
Toripalimab
Drug240 mg, IV infusion, Q3W
nab-Paclitaxel (nab-P)
Drug125 mg/m2, IV infusion, QW
Epirubicin (E)
Drug90 mg/m2, IV infusion, Q3W
Cyclophosphamide (C)
Drug600 mg/m2, IV infusion, Q3W
Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
The tpCR rate is defined as the proportion of participants with no residual invasive cancer cells in both the breast primary tumor site (residual in situ cancer cells are permitted) and all sampled axillary lymph nodes.
Breast Pathological Complete Response (bpCR) Rate: ypT0/Tis
The bpCR rate is defined as the proportion of participants with no residual invasive cancer cells in the breast primary tumor site (residual in situ cancer cells are permitted).
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a complete or partial response.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: precludes surgery, local or distant recurrence, second primary malignancy, or death due to any cause.
Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product, temporally associated with study intervention, without presumption of causality.
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