CI

At a glance

ClinicalIndex Comparison Record
Phase 4Recruiting· 1,072 target
Drug / intervention
Huaier Granuledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04790305
NCT04790305Phase 4RecruitingOn TrackUpdated 24mo ago
Long Recruiting

Effect of Huaier Granule on Postoperative Adjuvant Treatment for High-risk Early-stage Triple-negative Invasive Ductal Carcinoma: a Prospective, Multicenter, Randomized, Controlled, Open-label Study

Fudan University·interventional·Posted Mar 10, 2021·Updated Jun 27, 2024

In Brief

A Phase 4 clinical trial evaluating Huaier Granule for Carcinoma Breast and 2 related conditions. Currently recruiting, targeting 1,072 participants across 34 sites.

Detailed 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.

Study Details

Timeline

Phase 4Recruiting
20212022202320242025202620272028
First PostedMar 10, 2021
Enrollment StartJun 18, 2021
Primary CompletionDec 31, 2027
Study CompletionJul 28, 2028
TodayJul 1, 2026
Enrollment to primary: 6.5 yearsPosted 5.3 years agoPrimary completion in 1.5 years

Interventions

Huaier Granuledrug

The subjects in the experimental group will be treated with Huaier Granule continuously for 2 years or until the disease progressed, intolerable toxicity, withdrawal of informed consent form or died for any reason.