OncoMatch/Clinical Trials/NCT04790305
Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Is NCT04790305 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Huaier Granule for carcinoma breast.
Treatment: Huaier Granule — This is a prospective, multicenter, randomized, parallel controlled, open-label study. The primary purpose of this study is to evaluate the efficacy of Huaier Granule on postoperative adjuvant therapy of high-risk early-stage triple-negative invasive ductal carcinoma. The Secondary purposes are to evaluate the safety of long-term use of Huaier granules as postoperative adjuvant treatment of high-risk early-stage triple-negative invasive ductal carcinoma, and the changes of quality of life score after treatment with Huaier granule.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
neoadjuvant chemotherapy completed at least four cycles
Lab requirements
Blood counts
neutrophil count ≥ 1.5*10^9 / L, platelet count ≥ 100*10^9 / L, hemoglobin concentration ≥ 90 g / L (without transfusion)
Kidney function
serum creatinine level ≤ 1.5 × upper limit of normal (ULN)
Liver function
aspartate aminotransferase (AST) concentration / alanine aminotransferase (ALT) concentration ≤ 2.5 × ULN，total serum bilirubin concentration ≤ 1.5 × ULN
Hepatic function and renal function: serum creatinine level ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) concentration / alanine aminotransferase (ALT) concentration ≤ 2.5 × ULN，total serum bilirubin concentration ≤ 1.5 × ULN. Blood routine: neutrophil count ≥ 1.5*10^9 / L, platelet count ≥ 100*10^9 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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