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
1 other identifier
interventional
1,072
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2021
Longer than P75 for phase_4
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedStudy Start
First participant enrolled
June 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 28, 2028
June 27, 2024
June 1, 2024
6.5 years
March 5, 2021
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Start of treatment until 3-year follow-up
Secondary Outcomes (8)
3-year rates of overall survival
Start of treatment until 3-year follow-up
3-year rates of invasive-disease-free survival
Start of treatment until 3-year follow-up
5-year rates of disease-free survival
Start of treatment until 5-year follow-up
5-year rates of overall survival
Start of treatment until 5-year follow-up
5-year rates of invasive-disease-free survival
Start of treatment until 5-year follow-up
- +3 more secondary outcomes
Study Arms (2)
Huaier Granule + Conventional Treatment/visit
EXPERIMENTALHuaier 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
NO INTERVENTIONConventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- LinkDoc Technology (Beijing) Co. Ltd.collaborator
- Huazhong University of Science and Technologycollaborator
Study Sites (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, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhimin Shao, PhD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 10, 2021
Study Start
June 18, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
July 28, 2028
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share