OncoMatch/Clinical Trials/NCT06735131
The Optimal Radioimmunotherapy Combinations for Advanced TNBC
Is NCT06735131 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and chemotherapy regimen selected by the investigator for triple-negative breast cancer (tnbc).
Treatment: Toripalimab · chemotherapy regimen selected by the investigator — This study aims to explore the best combination patterns of radiotherapy and immunotherapy for advanced triple-negative breast cancer (TNBC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
ER <1%
Required: PR (PGR) expression <1% (<1%)
PR <1%
Required: HER2 (ERBB2) negative (IHC 0 or IHC 1+, or IHC 2+ but FISH negative) (IHC 0 or IHC 1+, or IHC 2+ but FISH negative)
HER2 negative as IHC 0 or IHC 1+, or IHC 2+ but negative upon fluorescence in situ hybridization (FISH) testing
Allowed: ESR1 expression ≤10% and unsuitable for endocrine therapy
Patients with ER/PR ≤10% and deemed unsuitable for endocrine therapy by the investigator are also eligible.
Allowed: PR (PGR) expression ≤10% and unsuitable for endocrine therapy
Patients with ER/PR ≤10% and deemed unsuitable for endocrine therapy by the investigator are also eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: for advanced/metastatic disease
No prior chemotherapy for advanced/metastatic disease.
Cannot have received: platinum-based chemotherapy
Exception: adjuvant/neoadjuvant therapy allowed if interval to recurrence/metastasis ≥6 months
Received platinum-containing regimens during the adjuvant/neoadjuvant therapy phase, and the interval from the last treatment to recurrence/metastasis is less than 6 months.
Cannot have received: radiation therapy
Exception: adjuvant radiotherapy allowed if there are lesions outside the previously irradiated field
Have received radiotherapy within 12 weeks prior to enrollment, unless the radiotherapy was for adjuvant purposes and there are lesions outside the previously irradiated field.
Lab requirements
Blood counts
Neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥90 g/L; No blood product transfusion or growth factor support within 2 weeks prior to examination
Kidney function
Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance >60 mL/min
Liver function
Serum total bilirubin (TBIL) ≤1.5×ULN; ALT and AST ≤2.5×ULN (≤5×ULN with liver metastases)
Adequate organ and bone marrow function, with specific requirements: Hematology: Neutrophil count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥90×10^9/L; Hemoglobin (Hb) ≥90 g/L; No blood product transfusion (including red blood cell and platelet products, etc.) or growth factor (including colony-stimulating factors, interleukins, and erythropoietin, etc.) support treatment within 2 weeks prior to examination. Liver function: Serum total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (for patients with liver metastases: ALT and AST ≤5×ULN). Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance >60 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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