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.
Single group
Ivonescimab
Druga PD-1/ VEGF Bispecific Antibody, 20mg/kg, every 2 weeks; Chemotherapy : paclitaxel and carboplatin, followed by epirubicin-cyclophosphamide
pathological complete response rate (pCR)
the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Event-free Survival (EFS) as assessed by Investigator
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Disease-free Survival (DFS) as assessed by Investigator
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
Distant Disease-free Survival (DDFS) as assessed by Investigator
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Objective response rate (ORR) in accordance with RECIST v1.1
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
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