Trial Title:
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
NCT ID:
NCT05860907
Condition:
Breast Cancer Stage IV
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
non-visceral metastasis
Huaier granule
randomized controlled
prospective clinical study
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier Granule
Description:
10g each time, three times a day
Arm group label:
Huaier Granule+Standard treatment
Other name:
Z20000109（NMPA Approval Number）
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijia Zhuang
Zip:
050011
Country:
China
Contact:
Last name:
Li Ma, PhD
Phone:
+8613932116886
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Contact:
Last name:
Xin Ge, PhD
Phone:
+8613303719081
Facility:
Name:
The First Hospital of Hunan University of Chinese Medicine
Address:
City:
Changsha
Zip:
410011
Country:
China
Contact:
Last name:
Jinhui Hu, PhD
Phone:
+8613637412178
Facility:
Name:
The Third Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Boni Ding, PhD
Phone:
+8613627418663
Facility:
Name:
Nantong First People's Hospital
Address:
City:
Nantong
Zip:
226006
Country:
China
Contact:
Last name:
Jinpeng Chen, PhD
Phone:
+8618551315594
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225001
Country:
China
Contact:
Last name:
Deyuan Fu, PhD
Phone:
+8618051060677
Facility:
Name:
The International Peace Maternity & Child Health Hospital of China welfare institute
Address:
City:
Shanghai
Zip:
200030
Country:
China
Contact:
Last name:
Jie Wang, PhD
Phone:
+8618017316231
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Zhimin Shao, PhD
Phone:
+8618017312288
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Liang Huang, PhD
Phone:
+8618121299334
Email:
fdhlyx@163.com
Facility:
Name:
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200092
Country:
China
Contact:
Last name:
Baosan Han, PhD
Phone:
+8618017312288
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Contact:
Last name:
Xiaojia Wang, PhD
Phone:
+8613906500190
Facility:
Name:
The First Hospital of Jiaxin
Address:
City:
Jiaxin
Zip:
314000
Country:
China
Contact:
Last name:
Caiping Chen, PhD
Phone:
+8613967370819
Facility:
Name:
Lishui Municipal Central Hospital
Address:
City:
Lishui
Zip:
323020
Country:
China
Contact:
Last name:
Shuzheng Chen, PhD
Phone:
+8613567618556
Facility:
Name:
Taizhou Central Hospital
Address:
City:
Taizhou
Zip:
318001
Country:
China
Contact:
Last name:
Yuechu Dai, PhD
Phone:
+8613906768336
Start date:
October 2023
Completion date:
October 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
LinkDoc Technology (Beijing) Co. Ltd.
Agency class:
Industry
Collaborator:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860907
