Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: * Age: 18-65 years old. * Diagnosis: Histologically and/or cytologically confirmed primary triple-negative breast cancer (TNBC) (excluding inflammatory breast cancer), meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis). TNBC Definition: Immunohistochemistry (IHC) showing ER and PR \<10%; HER2-negative: IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH). * Tissue Sample: Availability of tumor tissue sample for biomarker testing. * Measurable Disease: At least one measurable lesion according to RECIST v1.1 criteria. Lesions previously irradiated cannot be selected as target lesions. Subjects with only skin lesions or bone lesions are excluded. * Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 within 7 days prior to treatment initiation. * Adequate Organ and Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet …

✦ Analyst Commentary

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

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