This study is a multicenter, single-arm, investigator-initiated Phase II clinical trial. Eligible patients with treatment-naive early or locally advanced triple-negative breast cancer (TNBC), clinically staged as Stage II-III, will receive neoadjuvant therapy with ivonescimab in combination with chemotherapy prior to surgery. During the neoadjuvant phase, ivonescimab will be administered for a total of 12 doses. Patients who complete the neoadjuvant treatment and are deemed surgically eligible must undergo definitive surgical intervention.
Following surgery and pathological evaluation by the local pathology department at each participating center, patients will continue to receive adjuvant therapy with ivonescimab for an additional 14 doses, in addition to any subsequent treatment recommended by the investigator according to standard clinical practice.
The primary endpoint of this study is the pathological complete response rate (pCR). Participants will also be followed for secondary endpoints including event-free survival (EFS), disease-free survival (DFS), and distant disease-free survival (DDFS), with a minimum follow-up duration of 2 years post-surgery.
1. Age 18 to 75 years old, female.
1. Cancer-related history and treatment history: a. Bilateral breast cancer. b. History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). c. History of invasive or metastatic breast cancer. d. Prior surgical resection or biopsy of the primary breast tumor or axillary metastatic lymph nodes before informed consent was obtained.e. Diagnosis of any malignancy within 5 years prior to signing informed consent, except for cured cervical in situ carcinoma, basal cell carcinoma, or squamous cell carcinoma of the skin.f. Systemic chemotherapy, targeted therapy, or local radiotherapy within 1 year prior to signing informed consent. g. Prior treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other anti-PD-1/PD-L1 immunotherapies. h. Prior systemic treatment with anthracyclines, taxanes, or platinum-based agents for any malignancy.