A Randomized, Controlled, Open-label Clinical Trial of Adjuvant Intensive Therapy for HR+/ HER2-SNF4 Early Breast Cancer

Inclusion Criteria:

1. Women aged ≥18 years and ≤70 years;
2. Histologically confirmed HR+/HER2- invasive breast cancer (defined by immunohistochemical detection of ER \> 10% positive tumor cells were defined as ER positive, PR \> 10% positive tumor cells were defined as positive PR, and ER and/or PR were defined as positive HR. HER2 0-1+ or HER2 ++ but negative by FISH test, no amplification, defined as HER2 negative);
3. Definition of SNF4 subtype: SNF4 subtype confirmed by digital pathology of H\&E sections;
4. High-risk early breast cancer, which was pathologically confirmed as HR+/HER2- and SNF4 subtypes; pT2-4N0-3M0;
5. Complete the adjuvant chemotherapy selected by the doctor;
6. No more than 16 months from surgery to randomization, and no more than 12 weeks after non-endocrine therapy;
7. The functions of major organs are basically normal, meeting the following conditions:

   1. The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥75×109 /L;
   2. Biochemical examination shall meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
8. ECOG score 0 or 1;
9. Fertile female subjects are required to use a medically approved contraceptive for the duration of the study treatment and for at least 3 months after the last use of the study drug; The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. bilateral breast cancer;
2. A history of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
3. transfer of any part;
4. Pregnant or lactating women, women of childbearing age can not effectively contraceptive;
5. Patients participating in other clinical trials;
6. Severe organ dysfunction (heart, lung, liver and kidney); 50% (cardiac hypertrophy); Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, myocardial infarction, or cerebrovascular accident) within 6 months before randomization; Diabetics with poor blood sugar control;
7. Patients with a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), shall not be included in the group; If fecal occult blood (+), gastroscopy is required;
8. Abdominal fistula, gastrointestinal perforation, or abdominal abscess in the 28 days before the study;
9. Urine routine showed urine protein ≥++ or confirmed 24 hours urine protein quantity \> 1.0g;
10. Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90mmHg).
11. Allergic constitution, or known allergic history of the drug components of the program;
12. Previous thyroid dysfunction;
13. Severe or uncontrolled infection;
14. Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders; The researchers determined that the patients were not suitable for the study.