Randomized Controlled Clinical Study on the Reduction of Tumor Marker Levels in Breast Cancer Patients by Huaier Granules

Inclusion Criteria:

* 18 ≤ age ≤ 75 years old, regardless of gender.
* Postoperative pathological diagnosis of breast cancer.
* Imaging or pathological examination without evidence of recurrence or metastasis.
* If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
* One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
* The liver and kidney functions meet the following conditions: AST and ALT\< 3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine\<1.5 ULN;
* Other laboratory tests meet the following requirements: Hb ≥ 9g/dl, platelet count ≥ 60 × 10\^9/L, absolute neutrophil count\>1.0 × 10\^9/L.
* The patient's ECOG physical state score is 0 or 1.
* The subjects participated in this study voluntarily and signed an informed consent form.

Exclusion Criteria:

* Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate\>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ.
* Imaging or pathological confirmation of recurrence and metastasis.
* Serious infections (CTCAE\>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, excluding the use of prophylactic antibiotics.
* Suffering from severe acute and chronic diseases.
* Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
* Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women.
* Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
* The researcher believes that it is not suitable to participate in this study.