Back to resultsEffect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Primary Purpose
Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma Breast focused on measuring Huaier Granule, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast, Adjuvant Treatment
Eligibility Criteria
Inclusion Criteria:
- Aged from 18 to 70.
- Histologically confirmed as breast invasive ductal carcinoma.
- 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.
- 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 ) .]
- There was no local recurrence and distant metastasis of the tumor.
- The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
- 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.
- Blood routine: neutrophil count ≥ 1.5*109 / L, platelet count ≥ 100*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
- The participants volunteered to join the study with good compliance and signed an informed consent form.
Exclusion Criteria:
- Bilateral breast cancer.
- 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.
- 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.
- Allergic to Huaier granule.
- Pregnant or lactating women, and those who planning a pregnancy during the study period.
- Participating in other clinical trials or participated in other clinical studies within 3 months.
- Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- The First Affiliated Hospital of USTC, Anhui Provincial HospitalRecruiting
- Cancer Hospital Chinese Academy of Medical ScienceRecruiting
- The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
- Fujian Cancer HospitalRecruiting
- Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting
- Guangdong Provincial People's HospitalRecruiting
- The Fourth Hospital of Hebei Medical University, Hebei Tumor HospitalRecruiting
- The First Affiliates Hospital of Ha'erbin UniversityRecruiting
- Henan Provincial People's HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Tongji Medical College of HUSTRecruiting
- Union Hospital Tongji Medical College Huazhong Univeristy of Science and TechnologyRecruiting
- Zhongnan Hospital of Wuhan UniversityRecruiting
- Hunan Cancer HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Jiangsu Province Hospital of Chinese MedicineRecruiting
- Jiangsu Provincial HospitalRecruiting
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Northern Jiangsu People's HospitalRecruiting
- The Second Hospital of Jilin UniversityRecruiting
- Liaoning Cancer Hospital & InstituteRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- LongHua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)Recruiting
- The First Affiliatied Hospital Zhejiang University School of MedicineRecruiting
- The Second Affiliated Hospital Zhejiang Univerisity of MedicineRecruiting
- Huamei Hospital, University of Chinese Academy of SciencesRecruiting
- Ningbo Medical Center Lihuili HospitalRecruiting
- The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMURecruiting
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Huaier Granule + Conventional Treatment/visit
Conventional Treatment/visit
Arm Description
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.
Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
Outcomes
Primary Outcome Measures
3-year rates of disease-free survival
Disease-free survival (DFS)：The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, second primary invasive carcinoma (except breast cancer).
3-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 3 years.
Secondary Outcome Measures
3-year rates of overall survival
Overall survival (OS): The time from randomization until the date of death from any cause.
3-year rates of overall survival: The percentage of participants who have not died from any cause within 3 years.
3-year rates of invasive-disease-free survival
Invasive-disease-free survival (iDFS): The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, second primary invasive carcinoma (except breast cancer).
3-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 3 years.
5-year rates of disease-free survival
5-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 5 years.
5-year rates of overall survival
5-year rates of overall survival: The percentage of participants who have not died from any cause within 5 years.
5-year rates of invasive-disease-free survival
5-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 5 years.
Changes in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
Quality of Life (QOL) will be measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). The scope of each domain is 0 to 100. Higher scores in the functional and general health areas indicate better functional status and quality of life, and higher scores in the symptomatic areas indicate more symptoms or problems (poorer quality of life).
Incidence and severity of AE or SAE
AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
SAE: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Incidence and severity of ADR，SUSAR or SADR
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. A SADR is a serious ADR according to the above criteria of SAE. A SUSAR is an unexpected SADR.
Full Information
NCT ID
NCT04790305
First Posted
March 5, 2021
Last Updated
August 29, 2023
Sponsor
Fudan University
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04790305
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
July 28, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast
Keywords
Huaier Granule, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast, Adjuvant Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1072 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Huaier Granule + Conventional Treatment/visit
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Treatment/visit
Arm Type
No Intervention
Arm Description
Conventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Other Intervention Name(s)
Z20000109（NMPA Approval Number）
Intervention Description
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.
Primary Outcome Measure Information:
Title
3-year rates of disease-free survival
Description
Disease-free survival (DFS)：The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, second primary invasive carcinoma (except breast cancer).
3-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 3 years.
Time Frame
Start of treatment until 3-year follow-up
Secondary Outcome Measure Information:
Title
3-year rates of overall survival
Description
Overall survival (OS): The time from randomization until the date of death from any cause.
3-year rates of overall survival: The percentage of participants who have not died from any cause within 3 years.
Time Frame
Start of treatment until 3-year follow-up
Title
3-year rates of invasive-disease-free survival
Description
Invasive-disease-free survival (iDFS): The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, second primary invasive carcinoma (except breast cancer).
3-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 3 years.
Time Frame
Start of treatment until 3-year follow-up
Title
5-year rates of disease-free survival
Description
5-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 5 years.
Time Frame
Start of treatment until 5-year follow-up
Title
5-year rates of overall survival
Description
5-year rates of overall survival: The percentage of participants who have not died from any cause within 5 years.
Time Frame
Start of treatment until 5-year follow-up
Title
5-year rates of invasive-disease-free survival
Description
5-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 5 years.
Time Frame
Start of treatment until 5-year follow-up
Title
Changes in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire
Description
Quality of Life (QOL) will be measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). The scope of each domain is 0 to 100. Higher scores in the functional and general health areas indicate better functional status and quality of life, and higher scores in the symptomatic areas indicate more symptoms or problems (poorer quality of life).
Time Frame
Up to 5 years since the start of treatment
Title
Incidence and severity of AE or SAE
Description
AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
SAE: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame
Start of treatment until 3 year after enrollment
Title
Incidence and severity of ADR，SUSAR or SADR
Description
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. A SADR is a serious ADR according to the above criteria of SAE. A SUSAR is an unexpected SADR.
Time Frame
Start of treatment until 3 year after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 18 to 70.
Histologically confirmed as breast invasive ductal carcinoma.
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.
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 ) .]
There was no local recurrence and distant metastasis of the tumor.
The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
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.
Blood routine: neutrophil count ≥ 1.5*109 / L, platelet count ≥ 100*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
The participants volunteered to join the study with good compliance and signed an informed consent form.
Exclusion Criteria:
Bilateral breast cancer.
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.
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.
Allergic to Huaier granule.
Pregnant or lactating women, and those who planning a pregnancy during the study period.
Participating in other clinical trials or participated in other clinical studies within 3 months.
Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao, PhD
Phone
+86-18017312288
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Huang, PhD
Phone
+86-18121299334
Email
fdhlyx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingjie Zhang
Facility Name
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaopeng Ma
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Wang
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobing Yin
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Chen
Facility Name
Guangdong Provincial Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianjun Chen
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Wang
Facility Name
The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital
City
Shijia Zhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuizhi Geng
Facility Name
The First Affiliates Hospital of Ha'erbin University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhou
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Liu
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaojun Feng
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Tu
Facility Name
Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingrui Li
Facility Name
Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Huang
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaosong Wu
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongfang Li
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enxiang Zhou
Facility Name
Jiangsu Province Hospital of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Yao
Facility Name
Jiangsu Provincial Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shui Wang
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongzhong Yao
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxia Liu
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deyuan Fu
Facility Name
The Second Hospital of Jilin University
City
Chang chun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daqing Jiang
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifeng Yang
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Wang
Facility Name
LongHua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Liu
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuqun Zhang
Facility Name
The First Affiliatied Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peifen Fu
Facility Name
The Second Affiliated Hospital Zhejiang Univerisity of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiding Chen
Facility Name
Huamei Hospital, University of Chinese Academy of Sciences
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xujun Li
Facility Name
Ningbo Medical Center Lihuili Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weizhu Wu
Facility Name
The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMU
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ouchen Wang
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, PhD
Email
zhimingshao@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
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