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

Primary Purpose

Early-stage Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier granule
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-stage Breast Cancer focused on measuring Huaier granule, early-stage breast cancer, level of tumor markers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Huaier Granule

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
May 4, 2023
Last Updated
September 24, 2023
Sponsor
Fudan University
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05871437
Brief Title
Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Official Title
Clinical Study of Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Breast Cancer
Keywords
Huaier granule, early-stage breast cancer, level of tumor markers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
379 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Huaier Granule
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Huaier granule
Other Intervention Name(s)
Z20000109(NMPA Approval Number)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery rate of any tumor marker (CEA/CA125/CA153) to normal
Description
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
Time Frame
Start of treatment until 2-year follow-up
Secondary Outcome Measure Information:
Title
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
Description
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
Time Frame
Start of treatment until 2-year follow-up
Title
The incidence and severity of adverse reaction (ADR), severe adverse reactions(SADR), suspicious and unexpected severe adverse reaction (SUSAR)
Description
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
Time Frame
Start of treatment until 2-year follow-up
Title
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
Description
The rate of recovery of immune related cytokines to normal levels was detected at baseline, initial follow-up, and at the end of treatment.
Time Frame
The 3rd and 12th months after starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhimin Shao, PhD
Phone
+8618017312288
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Huang, PhD
Phone
+8618121299334
Email
fdhlyx@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhimin H Shao, PhD
Phone
+8618017312288
Email
zhimingshao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Liang Huang, PhD
Phone
+8618121299334
Email
fdhlyx@163.com
First Name & Middle Initial & Last Name & Degree
Zhimin Shao, PhD
First Name & Middle Initial & Last Name & Degree
Liang Huang, P

12. IPD Sharing Statement

Plan to Share IPD
No

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

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