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

Breast Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05860907
• Other study ID #: HE-202210-01
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer Stage IV
• Breast Neoplasms
• Neoplasm Metastasis

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