OncoMatch/Clinical Trials/NCT06401005
SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)
Is NCT06401005 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cadonilimab (AK104) for breast cancer.
Treatment: Cadonilimab (AK104) — Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with triple-negative breast cancer（TNBC）patients' overall survival (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to further improve the pCR rate of TNBC breast cancer became the main objective of this study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+ T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and efficacious in lung cancer patients. Cadonilimab (AK104) is an PD-1/CTLA-4 bispecific antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was proposed to explore the safety and efficacy of SBRT+AK104+chemotherapy, a neoadjuvant treatment modality, in the treatment of TNBC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (IHC <1%) (IHC <1%)
ER/PR immunohistochemistry negative or<1%
Required: PR (PGR) negative (IHC <1%) (IHC <1%)
ER/PR immunohistochemistry negative or<1%
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+/FISH-) (IHC 0, 1+, or 2+/FISH-)
Her2 immunohistochemistry of 0, 1+, or 2+/FISH-
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: within 12 months prior to first use of study drug
Received chemotherapy, targeted therapy, or radiation therapy within 12 months prior to first use of study drug
Cannot have received: targeted therapy
Exception: within 12 months prior to first use of study drug
Received chemotherapy, targeted therapy, or radiation therapy within 12 months prior to first use of study drug
Cannot have received: radiation therapy
Exception: within 12 months prior to first use of study drug
Received chemotherapy, targeted therapy, or radiation therapy within 12 months prior to first use of study drug
Cannot have received: immune checkpoint inhibitor
Who have received other antibodies/drugs targeting immune checkpoints in the past, such as anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte associated antigen- 4 (CTLA-4), and anti-cytotoxic T-lymphocyte associated antigen- 4 (CTLA-4), etc.
Lab requirements
Blood counts
white blood cell count (WBC) ≥ 2.0x10^9/L; neutrophil count (ANC) ≥ 1.5×10^9/L; platelet count (PLT) ≥ 100×10^9/L; hemoglobin (Hb) ≥ 90g/L
Kidney function
creatinine (Cr) ≤1.5 × ULN; if >1.5 × ULN, creatinine clearance needs to be ≥50mL/min (Cockcroft-Gault formula)
Liver function
total bilirubin (TBIL) ≤1.5 × ULN; glutamate aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN
Biochemical test indexes before enrollment must meet the following criteria, hematologic: white blood cell count (WBC) ≥ 2.0x10^9/L; neutrophil count (ANC) ≥ 1.5×10^9/L; platelet count (PLT) ≥ 100×10^9/L; hemoglobin (Hb) ≥ 90g/L; function: total bilirubin (TBIL) ≤1.5 × ULN; glutamate aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN; renal function: creatinine (Cr) ≤1.5 × ULN; if >1.5 × ULN, creatinine clearance needs to be ≥50mL/min (calculated according to Cockcroft-Gault formula); coagulation: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify