Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer

Study Overview
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Brief Summary
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This is a prospective, single center, single-arm, phase IV study， to evaluate the effect of Huaier Granule on reducing the level of tumor markers in early-stage breast cancer patients.

Detailed Description
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This clinical trial is expected to include 379 patients in the follow-up stage after breast cancer surgery who visited the Breast Surgery Department of Fudan University Shanghai Cancer Hospital from October 2022 to October 2024. Excluding cases where tumor markers (CEA/CA125/CA153) exceed the normal upper limit level in the case of recurrence and metastasis. All participants received treatment with Huaier granules for 1 year, or experienced intolerable toxicity, withdrew from the study for any reason or died, whichever occurred first. The main research indicator is the recovery rate of tumor markers (CEA/CA125/CA153) to normal.

Official Title
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Clinical Study of Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer

Conditions
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Early-stage Breast Cancer

Intervention / Treatment
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* Drug: Huaier granule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 ≤ age ≤ 75 years old, regardless of gender. 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: Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huaier Granule<br>Huaier Granules: oral administration, 10g once, 3 times a day, used for 1 year, or intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that they no longer benefit. If the patient experiences grade 3-5 (NCI CTC AE V5.0) adverse reactions related to Huai'er granules, and the adverse reactions do not recover after 2 weeks (returning to grade 1 or 2), it can be considered to reduce dosage or stop Huai'er granules treatment. If the medication is suspended for more than 2 weeks, the medication can be interrupted according to the judgment of the researcher. If the same adverse reaction occurs again, the Huaier granules will be permanently discontinued. | Drug: Huaier granule<br>* Huaier Granules: oral administration, 10g once, 3 times a day, used for 1 year, or intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that they no longer benefit. If the patient experiences grade 3-5 (NCI CTC AE V5.0) adverse reactions related to Huai'er granules, and the adverse reactions do not recover after 2 weeks (returning to grade 1 or 2), it can be considered to reduce dosage or stop Huai'er granules treatment. If the medication is suspended for more than 2 weeks, the medication can be interrupted according to the judgment of the researcher. If the same adverse reaction occurs again, the Huaier granules will be permanently discontinued.<br>* Other names: Z20000109（NMPA Approval Number）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of any tumor marker (CEA/CA125/CA153) to normal | The rate at which one or more tumor markers (CEA/CA125/CA153) exceed the upper limit of normal values before patient enrollment and any tumor marker that rises before enrollment decreases to the normal range after the end of Huaier Granule treatment | Start of treatment until 2-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events (AE) and severe adverse events (SAE) | The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population | Start of treatment until 2-year follow-up | 
| The incidence and severity of adverse reaction (ADR), severe adverse reactions(SADR), suspicious and unexpected severe adverse reaction (SUSAR) | The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population | Start of treatment until 2-year follow-up | 
| The rate at which immune related cytokines （IL-1β，IL-2，IL-4，IL-5，IL-6，IL-8，IL-10，IL-12，IL-17，TNF-α，IFN-α，IFN-γ）return to normal levels | The rate of recovery of immune related cytokines to normal levels was detected at baseline, initial follow-up, and at the end of treatment. | The 3rd and 12th months after starting treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaier granule, early-stage breast cancer, level of tumor markers