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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• The First Affiliated Hospital of USTC, Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• Cancer Hospital Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting
• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Zhimin Shao, PhD — Fudan University
• Study coordinator: Zhimin Shao, PhD
• Email: zhimingshao@yahoo.com
• Phone: +86-18017312288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.