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

Launched by FUDAN UNIVERSITY · Mar 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effect of a treatment called Huaier Granule for patients with high-risk early-stage triple-negative breast cancer after they have had surgery. The main goal is to see if Huaier Granule helps improve recovery and outcomes for patients who have this type of cancer, which can be more challenging to treat. Researchers will also look at how safe it is to use Huaier Granule over a longer period and if it improves the quality of life for patients.

To be eligible for this trial, participants should be between 18 and 70 years old and have been diagnosed with invasive ductal carcinoma that is confirmed to be triple-negative. They should not have any serious health issues that could affect their safety during the study, and must not have other types of cancer. Participants will be randomly assigned to receive either Huaier Granule or standard care after their surgery, and they will be monitored closely throughout the study to assess their health and well-being. This trial is currently recruiting participants, so those interested should talk to their healthcare provider for more information.

Gender

ALL

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.