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

NCT04790305 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1072

Last updated 2024-06-27

No results posted yet for this study

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.

Conditions

  • Carcinoma Breast
  • Triple-negative Breast Cancer
  • Invasive Ductal Carcinoma, Breast

Interventions

DRUG

Huaier Granule

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.

Sponsors & Collaborators

  • LinkDoc Technology (Beijing) Co. Ltd.

    collaborator INDUSTRY

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2027-12-31
Completion
2028-07-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04790305 on ClinicalTrials.gov