Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT04790305
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04790305
Study Brief:
Protocol Section:
NCT04790305