Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
NCT ID: NCT04790305
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1072 participants
INTERVENTIONAL
2021-06-18
2028-07-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Huaier Granule + Conventional Treatment/visit
Huaier Granule: oral administration, 20g each time, 3 times a day. The starting time of Huaier granule: from the beginning of adjuvant therapy to the end of adjuvant therapy, and within 60 days after the end of adjuvant therapy is also acceptable.
Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
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.
Conventional Treatment/visit
Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed as breast invasive ductal carcinoma.
3. Molecular typing of breast lesions is triple-negative breast cancer, when the patient had multicentric lesions at the same time, all invasive lesions were confirmed as triple-negative.
4. Regional lymph node metastasis confirmed by postoperative pathology \[except isolated tumor cells ( ITC )\], or tumor response did not achieve pathological complete response (pCR) after neoadjuvant therapy \[neoadjuvant chemotherapy completed at least four cycles, the breast has residual invasive cancer or axillary lymph node metastasis ( except isolated tumor cells ) .\]
5. There was no local recurrence and distant metastasis of the tumor.
6. The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
8. Hepatic function and renal function: serum creatinine level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) concentration / alanine aminotransferase (ALT) concentration≤ 2.5 × ULN，total serum bilirubin concentration≤ 1.5 × ULN.
9. Blood routine: neutrophil count ≥ 1.5\*109 / L, platelet count ≥ 100\*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
10. The participants volunteered to join the study with good compliance and signed an informed consent form.
Exclusion Criteria
2. Complicated with severe cardiopathy, hepatopathy, nephropathy, endocrine system diseases. According to the researchers' judgement, the comorbidities can cause unacceptable safety risks and affect participants' compliance with research programs.
3. Suffering from malignant tumors other than breast cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years.
4. Allergic to Huaier granule.
5. Pregnant or lactating women, and those who planning a pregnancy during the study period.
6. Participating in other clinical trials or participated in other clinical studies within 3 months.
7. Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.
18 Years
70 Years
ALL
No
Sponsors
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LinkDoc Technology (Beijing) Co. Ltd.
INDUSTRY
Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Principal Investigators
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Zhimin Shao, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Jingjie Zhang
Role: primary
Xiaopeng Ma
Role: primary
Xiang Wang
Role: primary
Guobing Yin
Role: primary
Xia Chen
Role: primary
Qianjun Chen
Role: primary
Kun Wang
Role: primary
Cuizhi Geng
Role: primary
Yi Zhou
Role: primary
Hui Liu
Role: primary
Yaojun Feng
Role: primary
Yi Tu
Role: primary
Xingrui Li
Role: primary
Tao Huang
Role: primary
Gaosong Wu
Role: primary
Dongfang Li
Role: primary
Enxiang Zhou
Role: primary
Chang Yao
Role: primary
Shui Wang
Role: primary
Yongzhong Yao
Role: primary
Jianxia Liu
Role: primary
Deyuan Fu
Role: primary
Yan Zhang
Role: primary
Daqing Jiang
Role: primary
Qifeng Yang
Role: primary
Haibo Wang
Role: primary
Sheng Liu
Role: primary
Shuqun Zhang
Role: primary
Peifen Fu
Role: primary
Yiding Chen
Role: primary
Xujun Li
Role: primary
Weizhu Wu
Role: primary
Ouchen Wang
Role: primary
Other Identifiers
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HE-202012
Identifier Type: -
Identifier Source: org_study_id
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