Spots Global Cancer Trial Database for Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
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Trial Identification
Brief Title: 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 ID: NCT05860907
Conditions
Interventions
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.
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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Fourth Hospital of Hebei Medical University, Shijia Zhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Nantong First People's Hospital, Nantong, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The International Peace Maternity & Child Health Hospital of China welfare institute, Shanghai, Shanghai, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The First Hospital of Jiaxin, Jiaxin, Zhejiang, China
Lishui Municipal Central Hospital, Lishui, Zhejiang, China
Taizhou Central Hospital, Taizhou, Zhejiang, China
Contact Details
Name: Zhimin Shao, Professor
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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