NCT04790305 Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
| NCT ID | NCT04790305 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fudan University |
| Condition | Carcinoma Breast |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,072 participants |
| Start Date | 2021-06-18 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,072 participants in total. It began in 2021-06-18 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Zhimin Shao, PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT04790305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Carcinoma Breast. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04790305 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04790305 currently recruiting?
Yes, NCT04790305 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT04790305 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Beijing, China, Chongqing, China and 11 additional locations.
Who is sponsoring the NCT04790305 clinical trial?
NCT04790305 is sponsored by Fudan University. The principal investigator is Zhimin Shao, PhD at Fudan University. The trial plans to enroll 1,072 participants.