NCT02615457

Huaier Granule in Treating Women With Triple Negative Breast Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo. PURPOSE: To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.

Detailed description

OBJECTIVES: Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group. OUTLINE: Patients are randomized to the following one of two treatment groups and are followed annually. Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. Arm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Huaier Granule	Huaier Granule was given orally, 20 g tid for 5 years.

Timeline

• Start date: 2015-10-01
• Primary completion: 2025-10-01
• First posted: 2015-11-26
• Last updated: 2015-11-26

Locations

1 site across 1 country: China