NCT07355361

Huaier Granule and Proteinuria

Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if adding Huaier Granule to standard care can treat proteinuria (excess protein in the urine) in adult female breast cancer patients (aged 18-75) who developed this condition as a side effect of their immunotherapy or anti-angiogenic cancer treatment. The main question it aims to answer is: \* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks? Researchers will compare the group receiving standard care plus Huaier Granule to the group receiving standard care alone to see if the combination is more effective at reducing protein levels in the urine. Participants will: * Be randomly assigned to one of the two study groups. * Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy). * Receive standard medical care for proteinuria from a kidney specialist. * If in the experimental group, take Huaier Granule orally, three times a day. * Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.

Conditions

• Proteinuria
• Breast Cancer Patients

Interventions

Type	Name	Description
DRUG	Huaier Granule	Huaier Granule Group: Participants will take Huaier Granule (Z20000109) on top of their standard treatment. The dosing is 10g, orally, three times a day. Treatment continues until the study ends, or an event such as disease progression, unacceptable side effects, withdrawal, or death occurs, whichever comes first. The investigator can also stop treatment if it's no longer deemed beneficial. Refer to the drug label for details. The investigator will decide on continued use if the background cancer therapy is changed due to progression.
DRUG	Antitumor therapy	The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
DRUG	Proteinuria Management	Specialist-managed care (including follow-up or drug therapy \[excluding Huaier Granule\]) initiated post-proteinuria diagnosis.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-06-15
• Completion: 2028-06-15
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: China