Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Early-stage Breast Cancer
About this trial
This is an interventional treatment trial for Early-stage Breast Cancer focused on measuring Huaier granule, early-stage breast cancer, level of tumor markers
Eligibility Criteria
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.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
Huaier Granule
Huaier Granules: oral administration, 10g once, 3 times a day, used for 1 year, or intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that they no longer benefit. If the patient experiences grade 3-5 (NCI CTC AE V5.0) adverse reactions related to Huai'er granules, and the adverse reactions do not recover after 2 weeks (returning to grade 1 or 2), it can be considered to reduce dosage or stop Huai'er granules treatment. If the medication is suspended for more than 2 weeks, the medication can be interrupted according to the judgment of the researcher. If the same adverse reaction occurs again, the Huaier granules will be permanently discontinued.