The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.
Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.
Age ≥ 18 years.
ECOG score ≤ 1.
Newly diagnosed, non-metastatic breast cancer of stage II-III, confirmed by histopathology or cytopathology (T1c-2 cN1-2 (≥2cm) or T3-4 cN0-2).
Prior exposure to drugs targeting the same therapeutic target as the study treatment drug planned for administration.
Radiotherapy, chemotherapy, surgery, or other targeted immunotherapy for triple-negative breast cancer before enrollment.
Uncontrolled central nervous system metastases (symptomatic or requiring glucocorticoids or mannitol for symptom control).
Inflammatory breast cancer, bilateral breast cancer, or occult breast cancer.