A Study of Immunotherapy Combined With Neoadjuvant Therapy Versus Neoadjuvant Therapy for Breast Cancer

Exclusion Criteria

• •1. Previously received any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
• •2. Patients who are concurrently receiving other anti-tumor therapy;
• •3. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
• •4. Stage IV breast cancer;
• •5. Intolerant to herbs or poor compliance;
• •6. With a history of any malignancies other than breast cancer in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
• •7. Severe heart, liver, kidney and other important organ dysfunction;
• •8. Inability to swallow, chronic diarrhea and intestinal obstruction, and having many factors that affect drug administration and absorption;
• •9. Participated in clinical trials of other drugs within 4 weeks before enrollment;
• •10. Known history of allergy to the drug components of this regimen; History of immunodeficiency, including HIV positive, HCV, live active hepatitis B or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
• •11. Have used drugs that affect immune function within 1 year;
• •12. Once suffered from any heart disease, including: (1) arrhythmia with clinical significance, (2) myocardial infarction; (3) heart failure; (4) investigator's judgment as not suitable for participating in this trial;
• •13. Pregnant, lactating women, fertile women with positive baseline pregnancy test or in the entire women of reproductive age who were unwilling to use effective contraception during the trial;
• •14. According to the investigator's judgment, there are comorbidities (including but) that seriously endanger the patient's safety or affect the patient's ability to complete the study not limited to severe hypertension, severe diabetes, active infection, etc., which cannot be controlled by drugs);
• •15. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia. The investigator considered the patient unsuitable for the study in any other case.