huaier granule on reducing the level of tumor markers in patients with early-stage breast cancer

Conditions: Early-stage Breast Cancer

Summary: this is a prospective, single center, single-arm, phase iv study， to evaluate the effect of huaier granule on reducing the level of tumor markers in early-stage breast cancer patients.

this clinical trial is expected to include 379 patients in the follow-up stage after breast cancer surgery who visited the breast surgery department of fudan university shanghai cancer hospital from october 2022 to october 2024. excluding cases where tumor markers (cea/ca125/ca153) exceed the normal upper limit level in the case of recurrence and metastasis. all participants received treatment with huaier granules for 1 year, or experienced intolerable toxicity, withdrew from the study for any reason or died, whichever occurred first. the main research indicator is the recovery rate of tumor markers (cea/ca125/ca153) to normal.

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.

Keywords: huaier granule early-stage breast cancer level of tumor markers