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.
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).
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.
Parallel
Huaier Granule
Drug10g each time, three times a day
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
Overall survival(OS)
The time from randomization to death (from any cause)
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
Objective response rate (ORR)
Proportion of patients whose breast cancer has shrunk to a predetermined volume and maintains a minimum time limit
Adverse reactions
Harmful reactions of Huaier granules that are unrelated to the purpose of the medication under normal usage and dosage
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
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Fudan University
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
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