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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 (Jun 2026). This Phase 4 trial studies Huaier Granule for carcinoma breast.

Phase 4RecruitingFudan UniversityNCT04790305Data as of Jun 2026Location: China

Treatment: Huaier GranuleThis 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.

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Extracted eligibility criteria

Treatments studied

Other

Huaier Granule

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT04790305 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received neoadjuvant chemotherapy.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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