Randomized Controlled Clinical Study on the Reduction of Tumor Marker Levels in Breast Cancer Patients by Huaier Granules
NCT ID: NCT05871437
Last Updated: 2025-09-08
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
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NOT_YET_RECRUITING
PHASE4
232 participants
INTERVENTIONAL
2025-09-30
2028-01-31
Brief Summary
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Detailed Description
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During the entire study period, the planned patient recruitment and enrollment duration is approximately 12 months, with a total follow-up duration of 12 months per participant. After enrollment, patients will be followed up every three months until the study concludes, or until the patient withdraws from the study for any reason or passes away.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Huaier Granule+Conventional clinical therapeutic drugs
Huai er Granules: Oral administration, 10g each time, three times a day, for one year. In case of intolerable toxicity, withdrawal from the study for any reason, or death, the first occurrence shall prevail. Or the researchers determine that they will no longer benefit. For specific usage, please refer to the drug instructions. For specific usage, please refer to the drug instructions.
Huaier granule
On the basis of routine clinical treatment/follow-up, take Huaier Granules orally, 10g each time, three times a day, for one year continuously or until disease progression, intolerable toxicity, withdrawal from the study for any reason or death occurs, whichever occurs first.
Conventional clinical therapeutic drugs
Treatment and follow-up were carried out in accordance with clinical routines
No interventions assigned to this group
Interventions
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Huaier granule
On the basis of routine clinical treatment/follow-up, take Huaier Granules orally, 10g each time, three times a day, for one year continuously or until disease progression, intolerable toxicity, withdrawal from the study for any reason or death occurs, whichever occurs first.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Postoperative pathological diagnosis of breast cancer.
* Imaging or pathological examination without evidence of recurrence or metastasis.
* If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
* One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
* 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.
* The patient's ECOG physical state score is 0 or 1.
* The subjects participated in this study voluntarily and signed an informed consent form.
Exclusion Criteria
* Imaging or pathological confirmation of recurrence and metastasis.
* Serious infections (CTCAE\>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and 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, excluding the use of prophylactic antibiotics.
* Suffering from severe acute and chronic diseases.
* Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
* Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women.
* Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
* The researcher believes that it is not suitable to participate in this study.
18 Years
75 Years
ALL
No
Sponsors
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LinkDoc Technology (Beijing) Co. Ltd.
INDUSTRY
Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Responsible Party
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Zhimin Shao
professor
Principal Investigators
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Zhimin Shao, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HE- 202504
Identifier Type: -
Identifier Source: org_study_id
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