Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis
NCT ID: NCT05860907
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
384 participants
INTERVENTIONAL
2023-10-31
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Clinical Study on the Reduction of Tumor Marker Levels in Breast Cancer Patients by Huaier Granules
NCT05871437
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
NCT06439771
The Study of Vidicizumab Combined With Tirelizumab in the Treatment of Breast Cancer With Low HER2 Expression
NCT05861635
H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study
NCT05167643
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
NCT06957886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Huaier Granule+Standard treatment
The subject is administered according to the clinical dosage and method of medication until disease progression occurs or the subject is unable to tolerate treatment.Subjects receiving routine diagnosis and treatment simultaneously.
Huaier Granule
10g each time, three times a day
Standard treatment
Subjects receive routine diagnosis and treatment without taking Huaier granules.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Huaier Granule
10g each time, three times a day
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LinkDoc Technology (Beijing) Co. Ltd.
INDUSTRY
Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhimin Shao
professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhimin Shao, Professor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 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 Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Li Ma, PhD
Role: primary
Xin Ge, PhD
Role: primary
Jinhui Hu, PhD
Role: primary
Boni Ding, PhD
Role: primary
Jinpeng Chen, PhD
Role: primary
Deyuan Fu, PhD
Role: primary
Jie Wang, PhD
Role: primary
Baosan Han, PhD
Role: primary
Xiaojia Wang, PhD
Role: primary
Caiping Chen, PhD
Role: primary
Shuzheng Chen, PhD
Role: primary
Yuechu Dai, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HE-202210-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.