triple-negative breast cancer (TNBC)
Conditions
Interventions
Experimental group:Ivonescimab Injection Combined with Nab-Paclitaxel Plus Lobaplatin
Sponsors
The First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Female breast cancer patients aged 18-75 years with a life expectancy >3 months; 2.Stage II-III TNBC confirmed by histology (specific definition: ER, PR negative defined as: immunohistochemistry detection ER 2 cm or nodal involvement (N+); 8.Organ function criteria: Hemoglobin (HB) >=9g/dL, Absolute Neutrophil Count (ANC) >=1.5×10^9/L, Platelet Count (PLT) >=100×10^9/L, Total Bilirubin (TBIL) ULN with Direct Bilirubin =60ml/min, Left Ventricular Ejection Fraction (LVEF) >=50% by echocardiogram, QT interval < 480 ms on 12-lead ECG; 9.Willingness to participate voluntarily, provision of informed consent, adherence to study protocol, and cooperation with follow-up assessments;
Exclusion criteria
Exclusion criteria: 1.History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 2.Patients with inflammatory breast cancer; 3.Histopathological diagnosis of breast neuroendocrine or metaplastic carcinoma; 4.Prior chemotherapy, radiotherapy, or targeted therapy within the last 12 months; 5.Previous treatment with anti-PD-1, PD-L1, PD-L2, or other T-cell surface inhibitory receptor-targeting agents (e.g., CTLA-4, OX-40, CD137); 6.Concurrent administration of any other anti-neoplastic therapy; 7.Participation in another clinical trial with investigational drugs within 4 weeks prior to enrollment; 8.Receipt of live vaccines within 30 days before the first study drug administration; 9.Active autoimmune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressive agents) within the past 2 years; 10.Diagnosis of immunodeficiency or receipt of systemic corticosteroids (>10 mg prednisone equivalent daily) or any form of immunosuppressive therapy within 7 days prior to the first study treatment; 11.History of Human Immunodeficiency Virus (HIV) infection; 12.Hepatitis B surface antigen (HBsAg) positivity with Hepatitis B Virus (HBV) DNA >=2000 IU/mL; for HBsAg positivity with HBV DNA <2000 IU/mL, at least 2 weeks of antiviral therapy against HBV is required prior to initial dosing. Hepatitis C Virus (HCV) antibody positivity with detectable HCV RNA; 13.History of non-infectious pneumonia requiring corticosteroid therapy or current pneumonia; 14.Active infection requiring systemic treatment; 15.Severe cardiovascular disease, including myocardial infarction, acute coronary syndrome, or coronary interventions (percutaneous coronary intervention/stenting/bypass surgery) within the last 6 months, or New York Heart Association Class II-IV congestive heart failure or a history of Class III-IV congestive heart failure; 16.Known hypersensitivity to any component of the study medication or its analogs; 17.Known history of active tuberculosis (tuberculosis, tubercle bacillus); 18.Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of reproductive age unwilling to use effective contraception throughout the study period; 19.History of significant neurological or psychiatric disorders, including epilepsy or dementia; 20.Any other condition deemed by the investigator as contraindicating participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response(tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival(EFS);invasive disease-free survival (iDFS);Breast pathological complete response(bpCR);Overall survival (OS);Objective response rate (ORR);Adverse Events(AE);Treatment-Related Adverse Event(TRAE);Serious Adverse Event(SAE); | — |
Countries
China
Contacts
Public ContactXaowei Qi
The First Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed