A Study of the Efficacy and Safety of Camrelizumab Plus Radiotherapy for Patients With Early Triple-Negative Breast
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。
• female participants aged ≥ 18 years and \< 75 years
• Participants with a histological or cytological diagnosis of TNBC breast cancer , defined by ER \<1%, PR \<1% and HER2 negative on IHC and/or non-amplified by ISH by local lab testing
• Gene detection for Subtypes of TNBC、PD-L1expression and TMB expression
• Breast-conserving therapy is planned after mastectomy 1) largest focus must measure of Primary tumor ≥ 5cm，Tumor invades breast skin and chest wall 2) Axillary lymph node metastasis≥4 3) 1 -3 lymph node metastases in stage T1-2 4) Simple mastectomy combined with axillary lymphadenectomy in stage T1-2 (axillary lymph nodes are positive, and subsequent axillary dissection is not considered)
• 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
• Women of childbearing potential must have a negative urine or serum pregnancy test within 28 day prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 90 days after the last dose of study medication.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.