Overview

Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer

Status:
Recruiting
Trial end date:
2028-07-28
Target enrollment:
0
Participant gender:
All
Summary
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.
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:

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.