Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)

Inclusion Criteria:

1. Female patients aged 18-75 years old;

2. ECOG score is 0-1 points;

3. breast cancer meets the following standards: Histologically confirmed invasivebreast cancer with tumor diameter>1cm (T1c-3; N0-3; M0). All patients werepathohistologically confirmed as HR+/HER2- breast cancer. According to the breastcancer diagnosis and treatment guidelines and specifications of the Chinese AntiCancer Association (2021 version), Luminal B is divided into Luminal B (HER2negative) and Luminal B (HER2 positive). Luminal B (HER2 negative) is ER/PRpositive, HER2 negative and Ki-67 proliferation index is high or PR low expression.Luminal type B (HER2 positive) is ER/PR positive, HER2 positive (proteinoverexpression or gene amplification), and Ki-67 in any state. Therefore, HR+/HER2-breast cancer is a Luminal type breast cancer patient excluding HER2+. Pathological examination of PD-L1 expression: The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our centerdetected the PD-L1 antibody site as 22C3.

4. The functional level of major organs must meet the following requirements (no bloodtransfusion within 2 weeks before screening, no use of...)

Using leukocyte and platelet boosting drugs:

1. Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109/L; plateletcount (PLT) greater than 75 × 109/L; Hemoglobin (Hb) is greater than 90g/L;Lymphocyte count ≥ 1.5 × 109/L

2. Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanineaminotransferase ALT and aspartate levels are less than 1.5 × ULN; Alkalinephosphatase is less than 2.5 × ULN; Urea nitrogen/ Urea (BUN/UREA) and creatinine (Cr) are less than 1.5 × ULN.

3. Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.

4. 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause orundergone surgical sterilization: during the treatment period and in the studytreatment, the final use effective contraceptive methods for at least 6 months aftera single administration.

5. Voluntarily join this study, sign an informed consent form, have good compliance,and are willing to cooperate with follow-up.

Exclusion Criteria:

1. Stage IV breast cancer.

2. Inflammatory breast cancer.

3. Previously received anti-tumor treatment or radiation therapy for any malignanttumor, excluding those that have been cured Malignant tumors such as cervicalcarcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.

4. Simultaneously undergoing anti-tumor treatment in other clinical trials, includingbut not limited to chemotherapy and endocrine therapy. Treatment, biologicaltherapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.

5. The patient had undergone major surgical procedures unrelated to breast cancerwithin 4 weeks before the first administration of the study drug, or the patient hasnot fully recovered from such surgical procedures.

6. Serious heart disease or discomfort, including but not limited to the followingdiseases:

1. Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).

2. High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rategreater than 100bpm, significant ventricular arrhythmias (such as ventriculartachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or thirddegree atrioventricular block).

3. Angina requiring medication for treatment. 4) Heart valve disease with clinicalsignificance. 5) ECG shows transmural myocardial infarction. 6) Poor control ofhypertension (systolic blood pressure greater than 180mmHg and/or diastolic bloodpressure greater than 180mmHg after drug treatment) 100mmHg). 7. Uncontrolled activeinfections that require treatment; History of immunodeficiency, including HIVtesting positive Sexual, or suffering from other acquired or congenitalimmunodeficiency diseases, or having a history of organ transplantation.

8. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitisB virus carriers, stable hepatitis B after drug treatment [HBV-DNA test negativeor<50IU/ml] and cured hepatitis C patients [HCV RNA test negative]).

9. Have received immunotherapy and experienced adverse immune events such as immunerelated pneumonia and myocarditis, which have been determined by researchers topotentially affect the safety of the experimental medication.

10. Individuals with a known history of allergies to the components of this medicationregimen.

11. Pregnant and lactating female patients, female patients with fertility and positivebaseline pregnancy test results, or reproductive age patients who are unwilling totake effective contraceptive measures during the entire trial period and within 6months after the last study medication.

12. Suffering from serious accompanying diseases or other comorbidities that mayinterfere with the planned treatment, or any other circumstances that the researcherdeems unsuitable for the patient to participate in this study.