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 (Jun 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
Treatments studied
Immunotherapy
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
Demographics
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.
Frequently asked questions
Is NCT04481763 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression <1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression <1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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