Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Stage IV
• Intervention / Treatment: Drug: Huaier Granule

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhimin Shao, PhD; Phone Number: +8618017312288; Email: zhimingshao@yahoo.com
• Study Contact Backup: Name: Liang Huang, PhD; Phone Number: +8618121299334; Email: fdhlyx@163.com

Study Locations

• China
  • Hebei
    • Shijia Zhuang, Hebei, China, 050011
      • The Fourth Hospital of Hebei Medical University
      • Contact: Li Ma, PhD; Phone Number: +8613932116886
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The first affiliated hospital of Zhengzhou university
      • Contact: Xin Ge, PhD; Phone Number: +8613303719081
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University
      • Contact: Boni Ding, PhD; Phone Number: +8613627418663
    • Changsha, Hunan, China, 410011
      • The First Hospital of Hunan University of Chinese Medicine
      • Contact: Jinhui Hu, PhD; Phone Number: +8613637412178
  • Jiangsu
    • Nantong, Jiangsu, China, 226006
      • Nantong First People's Hospital
      • Contact: Jinpeng Chen, PhD; Phone Number: +8618551315594
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
      • Contact: Deyuan Fu, PhD; Phone Number: +8618051060677
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center
      • Contact: Zhimin Shao, PhD; Phone Number: +8618017312288; Email: zhimingshao@yahoo.com
      • Contact: Liang Huang, PhD; Phone Number: +8618121299334; Email: fdhlyx@163.com
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Baosan Han, PhD; Phone Number: +8618017312288
    • Shanghai, Shanghai, China, 200030
      • The International Peace Maternity & Child Health Hospital of China Welfare Institute
      • Contact: Jie Wang, PhD; Phone Number: +8618017316231
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital
      • Contact: Xiaojia Wang, PhD; Phone Number: +8613906500190
    • Jiaxin, Zhejiang, China, 314000
      • The First Hospital of Jiaxin
      • Contact: Caiping Chen, PhD; Phone Number: +8613967370819
    • Lishui, Zhejiang, China, 323020
      • Lishui Municipal Central Hospital
      • Contact: Shuzheng Chen, PhD; Phone Number: +8613567618556
    • Taizhou, Zhejiang, China, 318001
      • Taizhou Central Hospital
      • Contact: Yuechu Dai, PhD; Phone Number: +8613906768336

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Huaier Granule+Standard treatment; The subject is administered according to the clinical dosage and method of medication until disease progression occurs or the subject is unable to tolerate treatment.Subjects receiving routine diagnosis and treatment simultaneously.	Drug: Huaier Granule; 10g each time, three times a day; Other Names: Z20000109（NMPA Approval Number）
No Intervention: Standard treatment; Subjects receive routine diagnosis and treatment without taking Huaier granules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival(OS)	The time from randomization to death (from any cause)	start of treatment until 3.5-year follow-up
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction rate of immune-related cytokines	During the treatment process, the decrease rate of immune related cytokines（Such as IL-1 β， IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12，IL-17，TNF- α， IFN- α， IFN- γ etc.） compared to the baseline period	The baseline period，12th week±14 days and 168th week±14 days

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Zhimin Shao, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled; Huaier granule; prospective clinical study; non-visceral metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neoplastic Processes; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: HE-202210-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No