NCT05860907

Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.

Detailed description

This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Huaier Granule	10g each time, three times a day

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2027-10-01
• First posted: 2023-05-16
• Last updated: 2023-09-26

Locations

13 sites across 1 country: China