NCT05871437

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

Prospective, Multicenter, Randomized Controlled Clinical Trial on the Effect of Huaier Granules in Reducing Tumor Marker Levels in Patients With Early-Stage Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a prospective, multicenter, randomized controlled clinical trial. Patients in the follow-up phase after breast cancer surgery were screened, excluding those with recurrence or metastasis, while having tumor markers (CEA/CA125/CA153) levels exceeding the upper limit of normal. A total of 232 patients were enrolled and randomly assigned to either the control group or the experimental group. They were followed up for one year, or until intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurred first; or until the investigator determined that no further benefit could be obtained. During the entire study period, the planned patient recruitment and enrollment duration is approximately 12 months, with a total follow-up duration of 12 months per participant. After enrollment, patients will be followed up every three months until the study concludes, or until the patient withdraws from the study for any reason or passes away.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Huaier granule	On the basis of routine clinical treatment/follow-up, take Huaier Granules orally, 10g each time, three times a day, for one year continuously or until disease progression, intolerable toxicity, withdrawal from the study for any reason or death occurs, whichever occurs first.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2023-05-23
• Last updated: 2025-09-08

Locations

1 site across 1 country: China