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

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Huazhong University of Science and Technology; LinkDoc Technology (Beijing) Co. Ltd.

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.