OncoMatch/Clinical Trials/NCT07371208
Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan (Sac-TMT) in Combination With KL-A167 for Neoadjuvant Treatment of Triple-Negative Breast Cancer
Is NCT07371208 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies SKB264 for breast cancer.
Treatment: SKB264 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 low expression (IHC <10%)
TNBC Definition: Immunohistochemistry (IHC) showing ER and PR <10%
Required: PR (PGR) low expression (IHC <10%)
TNBC Definition: Immunohistochemistry (IHC) showing ER and PR <10%
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH))
HER2-negative: IHC 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH)
Disease stage
Required: Stage CN0, CN1, CN2, CN3
Excluded: Stage DISTANT METASTASIS
meeting the criteria of tumor size ≥2 cm, clinical lymph node stage cN0 to cN3, and M0 (no distant metastasis)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: chemotherapy
Any prior chemotherapy ... for the currently diagnosed breast cancer prior to enrollment
Cannot have received: targeted therapy
Any prior ... targeted therapy ... for the currently diagnosed breast cancer prior to enrollment
Cannot have received: radiation therapy
Any prior ... radiotherapy for the currently diagnosed breast cancer prior to enrollment
Cannot have received: anti-PD-1 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
Cannot have received: TROP2-targeted therapy
Previous treatment with any TROP2-targeted therapy
Cannot have received: topoisomerase I inhibitor
Previous treatment with any ... topoisomerase I inhibitor
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 80 × 10⁹/L; Hemoglobin ≥ 10 g/dL
Kidney function
Creatinine clearance (Ccr) ≥ 60 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, and ALP ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN
Cardiac function
LVEF ≥ 55% by ECHO or MUGA
Adequate Organ and Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L; Hemoglobin ≥ 10 g/dL. Liver Function: AST, ALT, and ALP ≤ 2.5 × ULN; TBIL ≤ 1.5 × ULN. Renal Function: Creatinine clearance (Ccr) ≥ 60 mL/min (Cockcroft-Gault). Coagulation: INR, APTT, and PT ≤ 1.5 × ULN. Cardiac Function: LVEF ≥ 55% as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07371208 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 low expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR low expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage CN0 or CN1 or CN2 or CN3 is required.
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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