Evaluating Bemotuzumab to Improve the Efficacy of Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (TNBC)

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• 1. Pathological Staging a) Inflammatory breast cancer.b) Stage IV (metastatic) breast cancer, bilateral breast cancer, or multicentric breast cancer (defined as multifocal tumors involving more than one quadrant with lesions separated by ≥5 cm).
• 2. Tumor-Related Conditions a) Radiologic evidence of tumor invasion into major blood vessels or investigator-determined high risk of life-threatening hemorrhage due to impending vascular compromise.b) Uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium, >12 mg/dL serum calcium, or albumin-corrected serum calcium > upper limit of normal [ULN]); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy.c) Other severe concurrent illnesses interfering with treatment plans, including significant pulmonary conditions/diseases.
• 3. Prior/Concurrent Anticancer Therapies a) Previous or current systemic antitumor therapy for the current breast cancer (including chemotherapy, molecular targeted therapy, biologic therapy, or investigational agents).b) Participation in another clinical trial within 4 weeks prior to enrollment (3 months for monoclonal antibody trials) or planned participation during this study.c) Prior treatment with immune checkpoint inhibitors other than PD-1/PD-L1 monoclonal antibodies (e.g., CTLA-4 inhibitors) or anti-angiogenic agents (including monoclonal antibodies or TKIs).d) Administration of live/attenuated vaccines within 28 days before the first dose or anticipated vaccination during the study.
• 4. Medical History/Comorbidities a) Other malignancies within the past 5 years requiring systemic/local therapy (excluding cured carcinoma in situ, cervical intraepithelial neoplasia, basal/squamous skin cancer, or thyroid cancer).b) Major surgery within 28 days before the first dose (defined as requiring ≥3 weeks recovery) or palliative radiotherapy/ablation within 2 weeks.c) Known/suspected autoimmune diseases, except:Hypothyroidism managed with hormone replacement.Stable type 1 diabetes with controlled glycemia.d) Active viral hepatitis:HBV: HBsAg(+) or HBcAb(+) with HBV-DNA(+) (except those with HBV-DNA ≤2,500 copies/mL or 500 IU/mL after antiviral therapy).HCV: HCV-Ab(+) with HCV-RNA(+).Coinfection with HBV and HCV.e) HIV infection (HIV-Ab(+)).f) Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonitis).g) Severe infections:Hospital-required infections (e.g., bacteremia, pneumonia) within 4 weeks.Active CTCAE ≥Grade 2 infections requiring systemic antibiotics within 2 weeks.Unexplained fever >38.5°C during screening (tumor-related fever permitted per investigator).Active tuberculosis within 1 year.h) Prior allogeneic bone marrow or solid organ transplantation.i) Peripheral neuropathy ≥Grade 2 (CTCAE v5.0).j) History of neurological/psychiatric disorders (e.g., epilepsy, dementia), drug/alcohol abuse.k) Significant cardiac disease:Heart failure (LVEF <50%).High-risk arrhythmias (resting HR >100 bpm, ventricular tachycardia, Mobitz II/third-degree AV block).Unstable angina requiring antianginal therapy.Clinically significant valvular disease.ECG-confirmed transmural myocardial infarction.Uncontrolled hypertension (systolic >180 mmHg/diastolic >100 mmHg).
• 5. Treatment-Related Exclusions a) Systemic immunostimulants (e.g., interferon, interleukin-2) within 4 weeks before the first dose.b) Systemic immunosuppressants (e.g., glucocorticoids, azathioprine) within 2 weeks, except:Topical/inhaled corticosteroids.Physiologic steroid replacement (≤10 mg/day prednisone equivalent).c) Hypersensitivity to study drug components or severe allergic reactions to monoclonal antibodies.
• 6. Pregnancy/Lactation Pregnant/lactating women or women of childbearing potential with positive baseline pregnancy tests or unwilling to use effective contraception.
• 7. Investigator Discretion Any condition deemed by the investigator to compromise protocol compliance or patient safety.