| Eligibility |
Inclusion Criteria:
1. Voluntarily join this study and sign the informed consent form;
2. Female patients aged =18 years and =70 years old who are newly diagnosed with breast
cancer. According to the definition of the latest ASCO/CAP guidelines,
histopathologically confirmed ER+/HER2- breast cancer, histological grade II, Ki-67 =
20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;
3. According to RECIST 1.1, there is at least one measurable lesion;
4. ECOG score: 0~1;
5. Tumor tissue specimens that can be used for biomarker detection;
6. The function of vital organs meets the following requirements (no blood components or
cell growth factor drugs are allowed within 14 days before the first medication):
(1) Absolute neutrophil count =1.5×109/L; (2) Platelets =100×109/L; (3) Hemoglobin =90 g/L;
(4) Serum albumin =30 g/L; (5) Thyroid-stimulating hormone (TSH) =1×ULN (if abnormal, the
FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are
normal, you can be included in the group); (6) Serum total bilirubin =1.5×ULN; (7) ALT and
AST =2.5×ULN, if liver metastasis is present, ALT and AST =5ULN; (8) AKP=2.5×ULN; Serum
creatinine =1.5×ULN; (9) International normalized ratio (INR) =1.5 (not receiving
anticoagulant therapy).
Exclusion Criteria:
1. The presence of any active autoimmune disease or a history of autoimmune disease (such
as the following, but not limited to autoimmune hepatitis, interstitial pneumonia,
uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Those who
suffer from vitiligo or whose asthma has been completely relieved in childhood and do
not need any intervention in adulthood can be included; asthma that requires medical
intervention with bronchodilators cannot be included);
2. Are currently using immunosuppressants or systemic hormone therapy to achieve
immunosuppression (dose >10 mg/day prednisone or other effective hormones), and are
still using it within 2 weeks before enrollment;
3. Severe allergic reactions to other monoclonal antibodies;
4. Known history or evidence of interstitial lung disease or active non-infectious
pneumonia;
5. Those with known central nervous system metastasis;
6. Suffered from other malignant tumors in the past 5 years or at the same time (except
cured basal cell carcinoma of the skin and cervical cancer in situ);
7. Suffering from high blood pressure that cannot be well controlled by antihypertensive
drug treatment (systolic blood pressure =140 mmHg or diastolic blood pressure =90
mmHg); the above parameters are allowed to be achieved through the use of
antihypertensive treatment; there has been a hypertensive crisis or high blood
pressure in the past Hypertensive encephalopathy;
8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1)
NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction
within 1 year (4) Clinically significant supraventricular infarction or ventricular
arrhythmia requiring treatment or intervention (5) QTc>450ms (male); QTc>470ms
(female);
9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use
low-dose aspirin and low-molecular-weight heparin prophylactically;
10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3
months before enrollment; if fecal occult blood is positive during the baseline
period, it can be re-examined. If it is still positive after the reexamination, a
gastroscopy is required;
11. The tumor invades important blood vessels, or the researcher determines based on
imaging that there is a high possibility that the cancer will invade important blood
vessels in the future study period, which may lead to fatal bleeding;
12. Patients with pleural effusion, ascites or pericardial effusion that require drainage
can be enrolled if the researcher assesses that the symptoms are stable after
drainage;
13. Arterial/venous thrombosis events that occurred within 6 months before enrollment,
such as cerebrovascular accidents (including transient ischemic attack, cerebral
hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia
patients, coagulation disorders, etc.);
15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months before the start of study
treatment;
16. Urine routine shows urine protein = ++ and confirmed 24-hour urine protein amount >1.0
g;
17. Suffering from active infection, unexplained fever =38.5? within 7 days before taking
the drug, or baseline white blood cell count >15×109/L;
18. Those with congenital or acquired immune deficiency (such as HIV infection); those who
are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus
deoxyribonucleic acid (HBV DNA) = 2000 IU/ml, or hepatitis C virus antibody positive;
19. Have received live vaccines less than 4 weeks before study medication or may be
vaccinated during the study period;
20. In the judgment of the researcher, the patient has other factors that may affect the
study results or cause the study to be terminated midway, such as alcoholism, drug
abuse, other serious diseases (including mental illness) that require combined
treatment, and serious laboratory tests. Abnormalities, accompanied by family or
social factors, may affect the patient's safety.
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