Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks

Inclusion criteria

• Female, age 18-70 years.
• Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells >1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative).
• Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant chemotherapy.
• No prior treatment for present breast cancer onset.
• ECOG physical status score 0 to 1
• Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10^9/L, neutrophil count (ANC) ≥ 1.5×10^9/L, platelet count (PLT) ≥ 100×10^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value.
• No serious impairment of heart, liver, kidney and other important organ functions.

Exclusion criteria

• Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
• Women during pregnancy and breastfeeding after pregnancy.
• Women with proven distant metastases of breast cancer.
• Patients with proven sensory or motor nerve disease.
• Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
• Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
• History of other tumors.
• Allergic to the study drug or its excipients, etc.