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

NCT05871437 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: HE- 202504
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Huaier granule; breast cancer; level of tumor markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence and severity of adverse events (AE) and severe adverse events (SAE)

  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)

  Start of treatment until 2-year follow-up

• Quality of Life Score

  Start of treatment until 2-year follow-up

Study Arms (2)

Huaier Granule+Conventional clinical therapeutic drugs

EXPERIMENTAL

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

Conventional clinical therapeutic drugs

NO INTERVENTION

Treatment and follow-up were carried out in accordance with clinical routines

Interventions

Huaier granule DRUG

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.

Also known as: Z20000109（NMPA Approval Number）

Huaier Granule+Conventional clinical therapeutic drugs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhimin Shao, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhimin Shao, PhD

CONTACT

+8618017312288; zhimingshao@yahoo.com

Liang Huang, PhD

CONTACT

+8618121299334; fdhlyx@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 23, 2023
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)