Clinical Trial

Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer

Recruiting Phase 4
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Summary
This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-03-05; most recent amendment 2024-06-25.
Status change: Not Yet Recruiting → Recruiting 2021-07-20
Trial Details
NCT Number NCT04790305
Lead Sponsor Fudan University
Collaborators: LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
Conditions Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast
Enrollment 1,072 participants
Start Date 2021-06-18
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-07-28 (estimated)
Updated on ClinicalTrials.gov 2024-06-27