Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer

Study participants will receive the following treatments: HIFU therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy. Each cycle lasts 21 days. Subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
• Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
• Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.