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Huaier Granule for treating high-risk early-stage triple-negative breast cancer

Effect of Huaier Granule on Postoperative Adjuvant Treatment for High-risk Early-stage Triple-negative Invasive Ductal Carcinoma: a Prospective, Multicenter, Randomized, Controlled, Open-label Study

Phase 4 Interventional Fudan University · NCT04790305

This study is testing if adding Huaier Granule to standard treatment can help people with high-risk early-stage triple-negative breast cancer live longer and feel better.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment1072 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorFudan University Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations34 sites (Hefei, Anhui and 33 other locations)
Trial IDNCT04790305 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Huaier Granule as an adjuvant treatment for patients with high-risk early-stage triple-negative invasive ductal carcinoma. It is a multicenter, randomized, parallel-controlled, open-label study involving 1072 participants who will be divided into an experimental group receiving Huaier Granule alongside conventional treatment and a control group receiving conventional treatment only. The study aims to assess not only the effectiveness of Huaier Granule in improving disease-free survival and overall survival but also its safety and impact on quality of life over a follow-up period of five years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed triple-negative invasive ductal carcinoma and specific lymph node involvement.

Not a fit: Patients with localized recurrence or distant metastasis of the tumor may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with high-risk early-stage triple-negative breast cancer.

How similar studies have performed: Previous studies have shown promising results for Huaier Granule in improving survival rates in similar patient populations, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Aged from 18 to 70.
2. Histologically confirmed as breast invasive ductal carcinoma.
3. Molecular typing of breast lesions is triple-negative breast cancer, when the patient had multicentric lesions at the same time, all invasive lesions were confirmed as triple-negative.
4. Regional lymph node metastasis confirmed by postoperative pathology \[except isolated tumor cells ( ITC )\], or tumor response did not achieve pathological complete response (pCR) after neoadjuvant therapy \[neoadjuvant chemotherapy completed at least four cycles, the breast has residual invasive cancer or axillary lymph node metastasis ( except isolated tumor cells ) .\]
5. There was no local recurrence and distant metastasis of the tumor.
6. The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
7. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
8. 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.
9. Blood routine: neutrophil count ≥ 1.5\*109 / L, platelet count ≥ 100\*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
10. The participants volunteered to join the study with good compliance and signed an informed consent form.

Exclusion Criteria:

1. Bilateral breast cancer.
2. Complicated with severe cardiopathy, hepatopathy, nephropathy, endocrine system diseases. According to the researchers' judgement, the comorbidities can cause unacceptable safety risks and affect participants' compliance with research programs.
3. Suffering from malignant tumors other than breast cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) in the past 5 years.
4. Allergic to Huaier granule.
5. Pregnant or lactating women, and those who planning a pregnancy during the study period.
6. Participating in other clinical trials or participated in other clinical studies within 3 months.
7. Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.

Where this trial is running

Hefei, Anhui and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma BreastTriple-negative Breast CancerInvasive Ductal Carcinoma, BreastHuaier GranuleAdjuvant Treatment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.