This study is a multicenter phase II trial planning to enroll 40 patients with primary triple-negative breast cancer (tumor size ≥2 cm, clinical lymph node stage cN0-3, M0). Participants will receive the combination therapy of Sac-TMT and KL-A167 during the neoadjuvant treatment phase. The study aims to evaluate the efficacy and safety of Sac-TMT combined with KL-A167 as neoadjuvant treatment for triple-negative breast cancer.
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.
Cardiovascular Disease: Baseline left ventricular ejection fraction (LVEF) < 55% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or any other significant cardiovascular disease, or myocardial disease classified as New York Heart Association (NYHA) Class III or IV.
Prior Ipsilateral Breast Cancer: History of ipsilateral invasive breast cancer.
Prior Treatment for Current Breast Cancer: Any prior chemotherapy, targeted therapy, and/or radiotherapy for the currently diagnosed breast cancer prior to enrollment.
Prior Immune Checkpoint Inhibitor Therapy: Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Single group
SKB264
Drug1\) Neoadjuvant Treatment Phase Phase a: All eligible subjects will receive Sac-TMT (5 mg/kg, Day 1, every 2 weeks) combined with KL-A167 (900 mg, Day 1, every 2 weeks) for 6 cycles (12 weeks). At Week 12 (beginning of Week 13), radiographic assessment via contrast-enhanced breast MRI will be performed. Based on tumor response, patients proceed to Neoadjuvant Phase b: i. Responders (investigator-assessed Partial Response \[PR\] or Complete Response \[CR\]): Continue the same combination regimen for an additional 12 weeks of neoadjuvant therapy. ii. Non-responders (investigator-assessed Stable Disease \[SD\] or Progressive Disease \[PD\]): Switch to KL-A167 (900 mg every 2 weeks) combined with nab-paclitaxel (100 mg/m², Days 1, 8, 15, every 4 weeks per cycle) and carboplatin (AUC 2 mg·min/mL, Days 1, 8, 15, every 4 weeks per cycle) for 12 weeks.
pCR
ypT0/Tis ypN0
ORR
ORR per RECIST v1.1
EFS
EFS
OS
OS
Safety
Safety per NCI CTCAE 5.0
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