Clinical trial NCT05860907: Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
Official title: A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Breast Cancer Stage IV
Keywords: non-visceral metastasis
Huaier granule
randomized controlled
prospective clinical study
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
name: Huazhong University of Science and Technology
First posted: 2023-05-16
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Investigator evaluated progression free survival
timeFrame: start of treatment until 3.5-year follow-up
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: start of treatment until 3.5-year follow-up
measure: Clinical benefit rate (CBR)
timeFrame: start of treatment until 3.5-year follow-up
measure: Objective response rate (ORR)
timeFrame: start of treatment until 3.5-year follow-up
measure: Adverse reactions
timeFrame: start of treatment until 3.5-year follow-up
Other outcomes:
measure: Reduction rate of immune-related cytokines
timeFrame: The baseline period，12th week±14 days and 168th week±14 days
Locations:
city: Shijia Zhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: The International Peace Maternity & Child Health Hospital of China welfare institute
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Jiaxin
country: China
facility: The First Hospital of Jiaxin
state: Zhejiang
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Fudan University
name: Zhimin Shao, Professor
role: PRINCIPAL_INVESTIGATOR
References: