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

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Histologically or cytologically confirmed stage II-III (T1cN1-2 or T2-4N0-2) triple-negative breast cancer (TNBC), defined as: * Immunohistochemistry (IHC) showing ER and PR \<1% * HER2-negative per 2028 ASCO-CAP guidelines (IHC 0/1+ or IHC 2+/ISH-) 2. Available tumor tissue sample for biomarker analysis. 3. At least one measurable lesion as per RECIST 1.1 criteria. 4. ECOG performance status 0-1. 5. Adequate organ function as evidenced by: * Absolute neutrophil count ≥1.5×10⁹/L (no G-CSF support within 14 days) * Platelets ≥100×10⁹/L (no transfusion within 14 days) * Hemoglobin \>9 g/dL (no transfusion/ESA within 14 days) * Total bilirubin ≤1.5×ULN * AST/ALT ≤1.5×ULN * Alkaline phosphatase ≤2.5×ULN * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault) * INR/PT ≤1.5×ULN * TSH within normal range (or normal FT3/FT4 if TSH abnormal) * Normal cardiac enzymes (isolated abnormalities allowed if clinically insignificant…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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