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.