RecruitingPhase 4NCT04790305

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

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


Sponsor

Fudan University

Enrollment

1,072 participants

Start Date

Jun 18, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a traditional Chinese herbal medicine called Huaier Granule can improve outcomes when added to standard treatment for women with high-risk, early-stage triple-negative breast cancer (TNBC) — a type of breast cancer that is harder to treat because it does not respond to hormone therapies. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of invasive triple-negative breast cancer - You have either lymph node spread confirmed after surgery, OR your cancer did not achieve a complete response after pre-surgery chemotherapy - You have completed surgery for your breast cancer **You may NOT be eligible if...** - Your breast cancer is not triple-negative - You have metastatic (stage IV) breast cancer - You have not had surgery - You have serious organ conditions that would make you unable to tolerate treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuaier 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.


Locations(34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of USTC, Anhui Provincial Hospital

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital

Shijiazhuang, Hebei, China

The First Affiliates Hospital of Ha'erbin University

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Medical College of HUST

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, China

The First Affiliatied Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang Univerisity of Medicine

Hangzhou, Zhejiang, China

Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

Fudan University Shanghai Cancer Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT04790305