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

StatusNot Yet Recruiting
PhasePhase 4
Started2025-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 8, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-01
Recruiting→Not Yet Recruiting Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v3
Trial statusRecruiting→Not Yet Recruiting
Primary completion date2024-10→2026-01
Completion date2025-08→2028-01
Start date2023-05-08→2025-09
Enrollment target379→232
Study arms1→2
Secondary endpoints3 entries, revised
TheQuality rateof atLife which immune related cytokines （IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12，IL-17，TNF-α，IFN-α，IFN-γ）return to normal levelsScore
Study description+343 characters
This study is a prospective, multicenter, randomized controlled clinical trial is expected to include 379 patients. Patients in the follow-up stagephase after breast cancer surgery whowere visitedscreened, theexcluding Breastthose Surgerywith Departmentrecurrence ofor Fudanmetastasis, Universitywhile Shanghai Cancer Hospital from October 2022 to October 2024. Excluding cases wherehaving tumor markers (CEA/CA125/CA153) exceedlevels exceeding the normal upper limit levelof innormal. A total of 232 patients were enrolled and randomly assigned to either the casecontrol ofgroup recurrenceor andthe [...]
Study sitesdetails revised at 1 of 1 site
Study title+25 characters
HuaierRandomized GranuleControlled Clinical Study on Reducing the LevelReduction of Tumor MarkersMarker Levels in Patients With Early-stage Breast Cancer Patients by Huaier Granules
2023-09-24
Study Status, Arms and Interventions, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2023-08-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05→confirmed 2023-05-08
Study sites0→1
2023-05-12
Original filing
Fudan University
624 trials monitored
See 9 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group.
Trial Details
NCT Number NCT05871437
Lead Sponsor Fudan University
Collaborators: LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
Conditions Breast Cancer
Enrollment 232 participants
Start Date 2025-09
Primary Completion 2026-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-08