Spots Global Cancer Trial Database for Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
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Trial Identification
Brief Title: Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Official Title: 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
Study ID: NCT04790305
Interventions
Study Description
Brief 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.
Detailed Description: Triple-negative breast cancer（TNBC） accounts for 10% to 20% of breast cancer. TNBC is more likely to show lymph node involvement at diagnosis, and biologically more aggressive. Women with TNBC have a higher rate of distant recurrence at early-stage and a worse 5-year prognosis than women of other molecular types. Although PARP inhibitors and immune checkpoint inhibitors are showing promise to patients with advanced TNBC, however, these targeted therapies and immunotherapy for TNBC can not increase the clinical benefits of early-stage patients. As adjuvant therapy for hepatocellular carcinoma after curative liver resection, a multicentre study demonstrated a significant prolongation of RFS and reduced extrahepatic recurrence in Huaier group. Retrospective studies have shown that Huaier granules can improve the rates of disease-free survival（DFS） and overall survival（OS）, and reduce the incidence of adverse events among operable patients with TNBC. In this study, 1072 high-risk early-stage triple-negative invasive ductal carcinoma participants (536 cases in the observation group and 536 cases in the control group) from 30 research centers will be included. The block randomization was adopted, participants will be randomly divided into the experimental group (Huaier granule plus conventional treatment/visit) and control group (conventional treatment/visit only). All participants will be followed up for 5 years, including 2-year treatment follow-up and 3-year survival follow-up. During the treatment period, the participants will be followed up every 3 months, and the survival follow-up period will be followed up every 6 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, China
The Second Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 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, Shijia Zhuang, Hebei, China
The First Affiliates Hospital of Ha'erbin University, Ha'erbin, 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, Chang chun, 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, 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
Contact Details
Name: Zhimin Shao, PhD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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