A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)

Exclusion Criteria

• •1. LVEF \<50% by ECHO/MUGA or significant cardiac disease (NYHA Class III/IV).
• •2. Prior chemotherapy, targeted therapy, or radiotherapy for current breast cancer.
• •3. Previous treatment with immune checkpoint inhibitors (anti-PD-1/L1, anti-CTLA-4) or T-cell targeting therapies.
• •4. Prior Trop-2 directed therapy or topoisomerase I inhibitor treatment.
• •5. Other malignancies within 5 years (except adequately treated CIS of cervix, BCC, or cutaneous SCC).
• •6. Severe ocular surface disease (dry eye syndrome, meibomian gland dysfunction, or corneal disorders impairing healing).
• •7. Known hypersensitivity to study drug components.
• •8. History of immunodeficiency disorders or organ transplantation.
• •9. Current or history of:
• •* Steroid-requiring interstitial lung disease/pneumoniti Unresolved ILD/pneumonitis on screening imaging
• •Clinically significant pulmonary conditions including:
• •* Recent pulmonary embolism (≤3 months)
• •* Severe asthma/COPD/restrictive lung disease
• •* Pleural effusion requiring intervention
• •* Connective tissue disease with pulmonary involvement
• •* Prior pneumonectomy
• •10. Active autoimmune disease requiring systemic treatment (past 2 years), except:
• •* Hormone replacement therapy
• •* Physiologic corticosteroid replacement
• •11. Active infection requiring systemic therapy within 14 days prior to initiation.
• •12. Uncontrolled comorbidities that may:
• •* Compromise patient safety
• •* Interfere with study completion
• •13. Any condition that in the investigator's judgment may:
• •* Affect study drug evaluation
• •* Compromise safety assessments
• •* Interfere with data interpretation
• •* Otherwise contraindicate participation