| Eligibility |
Inclusion Criteria:
1. Histologically confirmed ER-/PR-/HER2- invasive breast cancer patients (ER/PR
immunohistochemistry negative or<1%; Her2 immunohistochemistry of 0, 1+, or 2+/FISH-)
patients; patients meeting one of the following conditions: (1) tumor mass larger than
2cm, (2) the presence of axillary lymph node metastasis, and (3) the desire to
conserve breasts, but the ratio of tumor size to breast volume is large and difficult
to conserve breasts;
2. Patients aged =18 years old;
3. ECOG score of 0-1;
4. Biochemical test indexes before enrollment must meet the following criteria,
hematologic: white blood cell count (WBC) = 2.0x10^9/L; neutrophil count (ANC) =
1.5×10^9/L; platelet count (PLT) = 100×10^9/L; hemoglobin (Hb) = 90g/L; function:
total bilirubin (TBIL) =1.5 × upper limit of normal (ULN); glutamate aminotransferase
(ALT) =3 × ULN; aspartate aminotransferase (AST) =3 × ULN; renal function: creatinine
(Cr) =1.5 × ULN; if >1.5 × ULN, creatinine clearance needs to be =50mL/min (calculated
according to Cockcroft-Gault formula); coagulation: activated partial thromboplastin
time (APTT) = 1.5 × ULN; prothrombin time (PT) or international normalized ratio (INR)
= 1.5 × ULN.
Exclusion Criteria:
1. Received chemotherapy, targeted therapy, or radiation therapy within 12 months prior
to first use of study drug;
2. Solid organ or blood system transplantation;
3. Myocardial infarction, poorly controlled arrhythmia (including QTc intervals = 470 ms)
within 6 months prior to first use of study drug (QTc intervals are calculated using
the Fridericia formula, which is: QTc=QT/RR ^0.33);
4. Class III-IV cardiac insufficiency according to NYHA criteria or cardiac ultrasound:
LVEF < 50%;
5. poorly controlled hypertension (defined as systolic blood pressure = 150 mmHg and/or
diastolic blood pressure = 100 mmHg), previous hypertensive crisis or hypertensive
encephalopathy;
6. Human immunodeficiency virus (HIV) infection, HIV-positive; active tuberculosis;
previous and current subjects with interstitial pneumonia, pneumoconiosis, radiation
pneumonitis, drug-associated pneumonitis, and severely impaired lung function that may
interfere with the detection and management of suspected drug-associated pulmonary
toxicity;
7. Known active or suspected autoimmune disease;
8. Subjects who are allowed to enroll in a stable state and do not require systemic
immunosuppressive therapy;
9. Who have received a live vaccine within 28 days prior to the first use of study drug;
however, inactivated viral vaccines for seasonal influenza are allowed;
10. Who require systemic treatment with corticosteroids (> 10 mg/day prednisone equivalent
dose) or other immunosuppressive medications within 14 days prior to the first use of
study drug or for the duration of the study. Subjects. However, enrollment will be
permitted in the absence of active autoimmune disease if the subject is treated with
topical or inhaled steroids (low potency), systemic short-term use in small doses,
single paracortical/intra-articular injections, or adrenocorticotropic hormone
replacement therapy at a dose of = 10 mg/day prednisone equivalent; and if any active
infections that require systemic administration of Active infection requiring systemic
administration of anti-infective therapy; subjects receiving prophylactic antibiotic
therapy (e.g., for prevention of urinary tract infections or chronic obstructive
pulmonary disease) are eligible for enrollment;
11. Hepatitis B (those with a positive Hepatitis B Surface Antigen [HBsAg] or Hepatitis B
Core Antibody [HBcAb] test and positive Hepatitis B Virus Deoxyribonucleic Acid
[HBV-DNA] test), Hepatitis C (those with a positive Hepatitis C Virus [HCV] antibody
test and positive Hepatitis C Virus [HBV] antibody test), and Hepatitis C (those with
a positive Hepatitis B virus [HCV] antibody test and positive Hepatitis C Virus [HCV]
antibody test) antibody test positive and hepatitis C virus ribonucleic acid [HCV-RNA]
test positive); subjects with hepatitis B and hepatitis C co-infection (positive HBsAg
or HBcAb test and positive HCV antibody test);
12. Who have received other antibodies/drugs targeting immune checkpoints in the past,
such as anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte associated antigen- 4
(CTLA-4), and anti-cytotoxic T-lymphocyte associated antigen- 4 (CTLA-4). 4 (CTLA-4),
etc.; are participating in another clinical study or are planning to start this study
treatment less than 14 days from the end of treatment in the previous clinical study;
13. Have undergone major surgery within 4 weeks prior to the first dose of study drug.
Definition of major surgery for this study: surgery that requires at least 3 weeks of
postoperative recovery time before receiving treatment on this study. Tumor puncture
or lymph node excision biopsy allowed for enrollment;
14. Pregnant or lactating females with a known history of severe allergy to any monoclonal
antibody or the study drug and its excipients;
15. Known history of psychotropic substance abuse or drug use; discontinued use of alcohol
allowed for enrollment;
16. Subjects with other factors that, in the judgment of the investigator, make them
unsuitable for participation in this study.
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