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Brief Title: Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Official Title: Clinical Study of Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Study ID: NCT05871437
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Name: Zhimin Shao, PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR