Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer

Other illness

• Bilateral breast cancer.
• Complicated with severe cardiopathy, hepatopathy, nephropathy, endocrine system diseases. According to the researchers' judgement, the comorbidities can cause unacceptable safety risks and affect participants' compliance with research programs.
• Suffering from malignant tumors other than breast cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years.
• Allergic to Huaier granule.

Other

• Pregnant or lactating women, and those who planning a pregnancy during the study period.
• Participating in other clinical trials or participated in other clinical studies within 3 months.
• Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.

• Aged from 18 to 70.
• Histologically confirmed as breast invasive ductal carcinoma.
• Molecular typing of breast lesions is triple-negative breast cancer, when the patient had multicentric lesions at the same time, all invasive lesions were confirmed as triple-negative.
• Regional lymph node metastasis confirmed by postoperative pathology \[except isolated tumor cells ( ITC )\], or tumor response did not achieve pathological complete response (pCR) after neoadjuvant therapy \[neoadjuvant chemotherapy completed at least four cycles, the breast has residual invasive cancer or axillary lymph node metastasis ( except isolated tumor cells ) .\]
• There was no local recurrence and distant metastasis of the tumor.
• The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
• Hepatic function and renal function: serum creatinine level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) concentration / alanine aminotransferase (ALT) concentration≤ 2.5 × ULN，total serum bilirubin concentration≤ 1.5 × ULN.
• Blood routine: neutrophil count ≥ 1.5\*109 / L, platelet count ≥ 100\*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
• The participants volunteered to join the study with good compliance and signed an informed consent form.