Clinical Research Directory

3.1 Inclusion Criteria Subjects must meet all of the following criteria to be eligible: Age and gender: Female, ≥18 years old. Histopathological confirmation: Invasive breast cancer confirmed by histopathology. No prior systemic anti-tumor therapy for breast cancer. Triple-negative PD-L1-positive breast cancer: ER/PR-negative (IHC nuclear staining \<10%). HER2-negative (IHC 0/1+ without FISH testing or IHC 2+ with FISH-negative amplification). PD-L1 Combined Positive Score (CPS) ≥1. Tumor stage: T1c-T2, N0-1 or T1a-T1b, N1 (per AJCC 8th Edition criteria). Measurable lesion: At least one measurable target lesion per RECIST v1.1. ECOG performance status: 0-1. Life expectancy: ≥3 months. Adequate organ and bone marrow function (within 1 month prior to treatment, without corrective therapy within 14 days before first dose): Bone marrow: Absolute neutrophil count (ANC) ≥2.0 ×10\^9/L. Platelets ≥100 ×10\^9/L. Hemoglobin ≥100 g/L. Liver/kidney function: Albumin ≥3.0 g/dL. Total bilirubin \<1.5 × ULN. ALT/AST \<1.5 × ULN. Alkaline phosphatase ≤2.5 × ULN. BUN and serum creatinine \<1.5 × ULN or creatinine clearance \>60 mL/min (Cockcroft-Gault formula). Coagulation: PT and APTT ≤1.5 × ULN. Cardiac function: LVEF ≥55% by echocardiography (ECHO). QT interval: QTcF ≤470 ms. Reproductive status: Premenopausal women: Negative serum pregnancy test within 14 days before treatment. Non-lactating. All subjects must use effective barrier contraception during treatment and for 6 months post-treatment. Informed consent: Willing to sign informed consent and comply with study procedures. 3.2 Exclusion Criteria Subjects meeting any of the following criteria will be excluded: Unconfirmed diagnosis: Breast cancer not histopathologically confirmed. Specific subtypes: Bilateral, inflammatory, or occult breast cancer. Metastatic disease: Evidence of metastatic breast cancer (excluded via chest/abdominal CT and bone scan; PET/CT allowed as alternative). Prior anti-tumor therapy: Chemotherapy, radiotherapy, targeted therapy, or endocrine therapy for breast cancer. Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks before first dose. Prior immunotherapy: Anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors. Concurrent anti-tumor therapy: Any other anti-cancer treatments during the study. Second primary malignancy: Except adequately treated non-melanoma skin cancer. Transplant history: Prior organ or bone marrow transplantation. Recent clinical trials: Participation in another drug trial within 4 weeks prior to enrollment. Immunosuppressive therapy: Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 2 weeks before first dose (excluding inhaled/topical steroids). Vaccination: Live or attenuated vaccines within 4 weeks before first dose. Major surgery: Non-breast-related major surgery within 4 weeks before first dose or incomplete recovery. Autoimmune diseases: Active autoimmune disease or history of autoimmune disease with potential recurrence (e.g., autoimmune hepatitis, uveitis, thyroid dysfunction requiring systemic treatment). Exceptions: Vitiligo, psoriasis, alopecia, controlled childhood asthma, or type 1 diabetes managed with insulin. Immunodeficiency: HIV-positive, congenital/acquired immunodeficiency disorders. Cardiovascular disease: History within 6 months: Myocardial infarction, stroke (excluding lacunar infarct), pulmonary embolism, unstable angina, NYHA Class III/IV heart failure. Clinically significant arrhythmia, primary cardiomyopathy, atrial fibrillation (EHRA ≥2b), uncontrolled hypertension, or QTcF \>470 ms. Pulmonary disease: Interstitial lung disease, idiopathic pulmonary fibrosis, severe COPD/asthma, or autoimmune/collagen vascular diseases with pulmonary involvement. Infections: Active hepatitis B (HBsAg+ with HBV DNA ≥500 IU/mL), hepatitis C (HCV RNA \> ULN), cirrhosis, or severe infections requiring antimicrobial therapy. Bleeding/thrombosis disorders: Hereditary/acquired bleeding or thrombotic tendencies (e.g., hemophilia). Hypersensitivity: Allergy or contraindication to study drug components. Pregnancy/lactation: Pregnant, breastfeeding, or unwilling to use contraception. Comorbidities: Uncontrolled conditions (e.g., hypertension, diabetes, active infections) contraindicating ADC or PD-L1 inhibitors. Neurological/psychiatric disorders: Epilepsy, dementia, or other conditions deemed unsuitable by the investigator.