Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University
About this trial
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
Qualifiers
Aged from 18 to 70.
Histologically confirmed as breast invasive ductal carcinoma.
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.
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 ) .]
Disqualifiers
Bilateral breast cancer.
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.
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.
Allergic to Huaier granule.
Trial design
Treatments tested in this trial
- Huaier Granule
Treatment groups
1,072 Participants
are divided into 2 treatment groupsLocations
34The First Affiliated Hospital of Anhui Medical University HefeiAnhui, China
The First Affiliated Hospital of USTC, Anhui Provincial Hospital HefeiAnhui, China
Cancer Hospital Chinese Academy of Medical Science BeijingBeijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University ChongqingChongqing Municipality, China
Sponsors and collaborators
Fudan University
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov