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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05860907
Other study ID # HE-202210-01
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date October 2023
Est. completion date October 2027

Study information

Verified date September 2023
Source Fudan University
Contact Zhimin Shao, PhD
Phone +8618017312288
Email zhimingshao@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.


Description:

This study used a blank control design and included at least 384 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 256 subjects in the experimental group and at least 128 subjects in the control group). Patients in the experimental group were treated with Huaier Granules (10g/dose, 3 times/day), while undergoing routine diagnosis and treatment; The control group received routine diagnosis and treatment, but did not take Huaier granules until the subjects experienced disease progression or intolerance.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 384
Est. completion date October 2027
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 18 years old = age = 75, regardless of gender. - For breast cancer patients who are clinically or pathologically diagnosed as non visceral metastasis, if the patient has only local recurrence or metastasis, the clinician judges that it is not suitable or refuses to use local treatment with radical intensity, such as surgical resection or radiotherapy. - Prior to enrollment, no more than first-line chemotherapy/endocrine therapy/targeted therapy/immunotherapy were allowed;If the patient has previously received first-line therapy, the outcome of treatment should be clinically assessed as disease progression or intolerance. - There is at least one measurable lesion that meets the RECIST 1.1 standard, or only bone metastases (including osteolytic lesions or mixed lesions). - The liver and kidney functions meet the following conditions: AST and ALT<3 ULN, total bilirubin = 2 ULN, and blood creatinine<1.5 ULN. - Other laboratory tests meet the following requirements: Hb = 9g/dl, platelet count = 60 × 10^9/L, absolute neutrophil count>1.0 × 10^9/L. - Expected survival time = 12 weeks. - The patient's ECOG physical state score is 0 or 1. - The subjects participated in the study voluntarily and signed an informed consent form. Exclusion Criteria: - Any other malignancies diagnosed within 5 years prior to enrollment, except those with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. - There is visceral metastasis of breast cancer. - Patients with advanced (local recurrence or metastasis) breast cancer who plan to receive radical local treatment. - Serious infections (CTCAE>Level 2) have occurred within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, except for prophylactic use of antibiotics. - Suffering from severe acute and chronic diseases. - Suffering from severe diabetes whose blood sugar cannot be effectively controlled. - Patients who cannot take oral medication or are allergic to the ingredients of Huaier granules. - Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance. - Pregnant or lactating women. - The researcher believes that it is not suitable to participate in this study.

Study Design


Intervention

Drug:
Huaier Granule
10g each time, three times a day

Locations

Country Name City State
China The First Hospital of Hunan University of Chinese Medicine Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China The First Hospital of Jiaxin Jiaxin Zhejiang
China Lishui Municipal Central Hospital Lishui Zhejiang
China Nantong First People's Hospital Nantong Jiangsu
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China The International Peace Maternity & Child Health Hospital of China welfare institute Shanghai Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China The Fourth Hospital of Hebei Medical University Shijia Zhuang Hebei
China Taizhou Central Hospital Taizhou Zhejiang
China Northern Jiangsu People's Hospital Yangzhou Jiangsu
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (3)

Lead Sponsor Collaborator
Fudan University Huazhong University of Science and Technology, LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Reduction rate of immune-related cytokines During the treatment process, the decrease rate of immune related cytokines(Such as IL-1 ß, IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12,IL-17,TNF- a, IFN- a, IFN- ? etc.) compared to the baseline period The baseline period,12th week±14 days and 168th week±14 days
Primary Investigator evaluated progression free survival The time from randomization to the first occurrence of disease progression or death from any cause. As long as the subject experiences either "disease progression" or "death" first, it reaches the endpoint of the study start of treatment until 3.5-year follow-up
Secondary Overall survival(OS) The time from randomization to death (from any cause) start of treatment until 3.5-year follow-up
Secondary Clinical benefit rate (CBR) The percentage of patients with advanced breast cancer who achieved a complete response, partial response, or stable disease for at least six months after treatment start of treatment until 3.5-year follow-up
Secondary Objective response rate (ORR) Proportion of patients whose breast cancer has shrunk to a predetermined volume and maintains a minimum time limit start of treatment until 3.5-year follow-up
Secondary Adverse reactions Harmful reactions of Huaier granules that are unrelated to the purpose of the medication under normal usage and dosage start of treatment until 3.5-year follow-up
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