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

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

NCT ID: NCT05871437

Condition: Early-stage Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Huaier granule
early-stage breast cancer
level of tumor markers

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Huaier granule
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.
Arm group label: Huaier Granule

Other name: Z20000109（NMPA Approval Number）

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Zhimin H Shao, PhD

Phone: +8618017312288
Email: zhimingshao@yahoo.com

Contact backup:
Last name: Liang Huang, PhD

Phone: +8618121299334
Email: fdhlyx@163.com

Investigator:
Last name: Zhimin Shao, PhD
Email: Principal Investigator

Investigator:
Last name: Liang Huang, P
Email: Sub-Investigator

Start date: May 8, 2023

Completion date: August 2025

Lead sponsor:
Agency: Fudan University
Agency class: Other

Collaborator:
Agency: LinkDoc Technology (Beijing) Co. Ltd.
Agency class: Industry

Collaborator:
Agency: Huazhong University of Science and Technology
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05871437