Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

Exclusion Criteria

• •1. Patients with metastatic breast cancer (Stage IV).
• •2. Baseline left ventricular ejection fraction (LVEF) \<50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.
• •3. Chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer before enrollment.
• •4. Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.
• •5. A history of other malignancies within the past 5 years, excluding cured cervical in situ carcinoma, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
• •6. Known allergy to the study drug or its components.
• •7. A history of immunodeficiency or organ transplantation.
• •8. Documented severe dry eye syndrome, severe meibomian gland disease, and/or blepharitis, or a history of corneal diseases that may impede delayed corneal healing.
• •9. A history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspicious ILD or non-infectious pneumonia at screening that cannot be excluded by imaging studies; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a history of pneumonectomy.
• •10. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as Type I diabetes, hypothyroidism requiring only thyroid hormone replacement, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement).
• •11. Active infection requiring systemic treatment within 2 weeks before the first dose.
• •12. Any comorbidities that, in the investigator's judgment, pose a serious risk to patient safety or may affect the patient's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc.
• •13. Any condition or other circumstances that the investigator believes may interfere with the evaluation of the study drug, the safety of the subject, or the interpretation of the study results, or any other condition that the investigator deems unsuitable for participation in this study.