OncoMatch/Clinical Trials/NCT06402435
SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Luminal-type Breast Cancer
Is NCT06402435 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lvonescimab (AK112) for breast cancer.
Treatment: Lvonescimab (AK112) — Studies have indicated that the improvement in pathological complete response (pCR) is significantly correlated with luminal breast cancer patients' overall survival (OS). Patients with luminal breast cancer have poor efficacy for neoadjuvant chemotherapy. The combination of neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the pCR rate of luminal-type breast cancer patients, increasing it from 13-15% to approximately 24%. Therefore, how to further improve the pCR rate of luminal-type 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. Ivonescimab (AK112) is an anti-PD-1/VEGF-A 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+AK112+chemotherapy, a neoadjuvant treatment modality, in the treatment of luminal breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 hormone receptor positive
HR+
Required: HER2 (ERBB2) negative (IHC 0, 1+, or 2+/FISH-) (IHC 0, 1+, or 2+/FISH-)
HER2-negative (HER2 immunohistochemistry 0, 1+, or 2+/FISH-)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Received chemotherapy, targeted therapy, or radiotherapy within 12 months before the first dose of the investigational drug
Cannot have received: targeted therapy
Received chemotherapy, targeted therapy, or radiotherapy within 12 months before the first dose of the investigational drug
Cannot have received: radiotherapy
Received chemotherapy, targeted therapy, or radiotherapy within 12 months before the first dose of the investigational drug
Cannot have received: immune checkpoint inhibitor
history of prior treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies)
Lab requirements
Blood counts
WBC ≥2.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L
Kidney function
serum creatinine ≤1.5×ULN, or if Cr exceeds this limit, creatinine clearance rate ≥50 mL/min (Cockcroft-Gault formula)
Liver function
TBIL ≤1.5×ULN; ALT and AST ≤3×ULN
baseline laboratory values within acceptable ranges: WBC ≥2.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L. Liver function parameters must be within ≤1.5×ULN for TBIL and ≤3×ULN for ALT and AST. Renal function must be preserved, with serum creatinine ≤1.5× ULN, or if Cr exceeds this limit, the creatinine clearance rate should be ≥50 mL/min (Cockcroft-Gault formula).
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