OncoMatch/Clinical Trials/NCT04481763
A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
Is NCT04481763 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Camrelizumab for triple-negative breast cancer.
Treatment: Camrelizumab — This is a open-labeled, single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with radiotherapy in patients with early triple-negative breast cancer. We will enroll 60 subjects. This study aims to evaluate the efficacy and safety of camrelizumab combined with radiotherapy in the treatment of early 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) wild-type (negative on IHC and/or non-amplified by ISH)
HER2 negative on IHC and/or non-amplified by ISH
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin ≥5.6mmol/L（9.0g/dL) serum albumin ≥2.8g/dL
Kidney function
Serum creatinine ≤ ≤1.5mg/d or creatinine clearance ≥ 50mL/min
Liver function
Serum Total Bilirubin ≤ 1.5 X ULN AST&ALT≤2.5ULN
Cardiac function
12 lead ECG: friderica corrected QT interval (QTCF) < 470 Ms
Adequate Organ Function as defined in the table below: Absolute neutrophil count (ANC) ≥ 1500/uL Platelet count ≥ 100,000/uL Hemoglobin ≥5.6mmol/L（9.0g/dL) serum albumin ≥2.8g/dL Serum creatinine ≤ ≤1.5mg/d or creatinine clearance ≥ 50mL/min Serum Total Bilirubin ≤ 1.5 X ULN AST&ALT≤2.5ULN 12 lead ECG: friderica corrected QT interval (QTCF) < 470 Ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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