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

Sponsor

Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05860907

Collaborator

LinkDoc Technology (Beijing) Co. Ltd. (Industry), Huazhong University of Science and Technology (Other)

341

Enrollment

Locations

Arms

Anticipated Duration (Months)

26.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Stage IV	Drug: Huaier Granule	Phase 4

Detailed Description

This study used a blank control design and included at least 341 subjects. The experimental group and control group were randomized in a 2:1 ratio (at least 228 subjects in the experimental group and at least 113 subjects in the control group). Patients in the experimental group were treated with Huai Er Granules (20g/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 Design

Study Type:

Interventional

Anticipated Enrollment :

341 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

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 20g 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.

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

20g 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.

Outcome Measures

Primary Outcome Measures

Investigator evaluated progression free survival [start of treatment until 3.5-year follow-up]
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

Secondary Outcome Measures

Overall survival(OS) [start of treatment until 3.5-year follow-up]
The time from randomization to death (from any cause)
Clinical benefit rate (CBR) [start of treatment until 3.5-year follow-up]
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
Objective response rate (ORR) [start of treatment until 3.5-year follow-up]
Proportion of patients whose breast cancer has shrunk to a predetermined volume and maintains a minimum time limit
Adverse reactions [start of treatment until 3.5-year follow-up]
Harmful reactions of Huaier granules that are unrelated to the purpose of the medication under normal usage and dosage

Other Outcome Measures

Reduction rate of immune-related cytokines [The baseline period，12th week±14 days and 168th week±14 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fourth Hospital of Hebei Medical University	Shijia Zhuang	Hebei	China	050011
2	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
3	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan	China	410011
4	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013
5	Nantong First People's Hospital	Nantong	Jiangsu	China	226006
6	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu	China	225001
7	The International Peace Maternity & Child Health Hospital of China welfare institute	Shanghai	Shanghai	China	200030
8	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
9	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200092
10	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310005
11	The First Hospital of Jiaxin	Jiaxin	Zhejiang	China	314000
12	Lishui Municipal Central Hospital	Lishui	Zhejiang	China	323020
13	Taizhou Central Hospital	Taizhou	Zhejiang	China	318001