Randomized Controlled Clinical Study on the Reduction of Tumor Marker Levels in Breast Cancer Patients by Huaier Granules

Prospective, Multicenter, Randomized Controlled Clinical Trial on the Effect of Huaier Granules in Reducing Tumor Marker Levels in Patients With Early-Stage Breast Cancer

This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the rate of reduction of tumor markers to normal levels in breast cancer patients treated with Huaier granules compared to the control group.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Huaier granule

Detailed Description

This study is a prospective, multicenter, randomized controlled clinical trial. Patients in the follow-up phase after breast cancer surgery were screened, excluding those with recurrence or metastasis, while having tumor markers (CEA/CA125/CA153) levels exceeding the upper limit of normal. A total of 232 patients were enrolled and randomly assigned to either the control group or the experimental group. They were followed up for one year, or until intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurred first; or until the investigator determined that no further benefit could be obtained.

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.

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhimin Shao, PhD; Phone Number: +8618017312288; Email: zhimingshao@yahoo.com
• Study Contact Backup: Name: Liang Huang, PhD; Phone Number: +8618121299334; Email: fdhlyx@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
      • Contact: Liang Huang, PhD; Phone Number: +8618121299334; Email: fdhlyx@163.com
      • Contact: Zhimin H Shao, PhD; Phone Number: +8618017312288; Email: zhimingshao@yahoo.com
      • Principal Investigator: Zhimin Shao, PhD
      • Sub-Investigator: Liang Huang, P

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 Names: Z20000109（NMPA Approval Number）
No Intervention: Conventional clinical therapeutic drugs; Treatment and follow-up were carried out in accordance with clinical routines

What is the study measuring?

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
Quality of Life Score	Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.	Start of treatment until 2-year follow-up

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Zhimin Shao, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: breast cancer; Huaier granule; level of tumor markers
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: HE- 202504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No