Actively Recruiting
Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Led by Fudan University · Updated on 2024-06-27
1072
Participants Needed
34
Research Sites
371 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
L
LinkDoc Technology (Beijing) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from 18 to 70.
- Histologically confirmed as breast invasive ductal carcinoma.
- Molecular typing of breast lesions is triple-negative breast cancer; if multicentric lesions, all must be triple-negative.
- Regional lymph node metastasis confirmed by postoperative pathology, excluding isolated tumor cells.
- Residual invasive cancer or axillary lymph node metastasis after completing at least four cycles of neoadjuvant chemotherapy.
- No local recurrence or distant metastasis of the tumor.
- Randomization during postoperative adjuvant therapy or within 60 days after its completion.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Hepatic and renal function within specified laboratory limits.
- Adequate blood counts: neutrophils ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L without transfusion.
- Voluntary participation with good compliance and signed informed consent form.
You will not qualify if you...
- Bilateral breast cancer.
- Severe heart, liver, kidney, or endocrine diseases posing safety risks or affecting compliance.
- Other malignant tumors within the past 5 years, except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- Allergy to Huaier granule.
- Pregnant, lactating, or planning pregnancy during the study.
- Participation in other clinical trials within the last 3 months.
- Poor compliance or other reasons deemed inappropriate by researchers.
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Trial Site Locations
Total: 34 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
2
The First Affiliated Hospital of USTC, Anhui Provincial Hospital
Hefei, Anhui, China
Actively Recruiting
3
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Actively Recruiting
4
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
5
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
6
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
7
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
8
The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
9
The First Affiliates Hospital of Ha'erbin University
Harbin, Heilongjiang, China
Actively Recruiting
10
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
11
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
12
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
13
Tongji Medical College of HUST
Wuhan, Hubei, China
Actively Recruiting
14
Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
15
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
16
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
17
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
18
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, China
Actively Recruiting
19
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
Actively Recruiting
20
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Actively Recruiting
21
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
22
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Actively Recruiting
23
The Second Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
24
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
25
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
26
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
27
LongHua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
28
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, China
Actively Recruiting
29
The First Affiliatied Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
30
The Second Affiliated Hospital Zhejiang Univerisity of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
31
Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
Actively Recruiting
32
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Actively Recruiting
33
The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMU
Wenzhou, Zhejiang, China
Actively Recruiting
34
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, PhD
CONTACT
L
Liang Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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