Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast
About this trial
This is an interventional treatment trial for Carcinoma Breast focused on measuring Huaier Granule, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast, Adjuvant Treatment
Eligibility Criteria
Inclusion Criteria:
- 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 ) .]
- There was no local recurrence and distant metastasis of the tumor.
- The time of randomization is during the postoperative adjuvant therapy or within 60 days after the end of the last postoperative adjuvant therapy.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1.
- 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.
- Blood routine: neutrophil count ≥ 1.5*109 / L, platelet count ≥ 100*109 / L, hemoglobin concentration ≥ 90 g / L (without transfusion).
- The participants volunteered to join the study with good compliance and signed an informed consent form.
Exclusion Criteria:
- 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.
- Pregnant or lactating women, and those who planning a pregnancy during the study period.
- Participating in other clinical trials or participated in other clinical studies within 3 months.
- Patients with a poor compliance, or they are not appropriate for this study because of other reasons considered by the researchers.
Sites / Locations
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- The First Affiliated Hospital of USTC, Anhui Provincial HospitalRecruiting
- Cancer Hospital Chinese Academy of Medical ScienceRecruiting
- The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
- Fujian Cancer HospitalRecruiting
- Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting
- Guangdong Provincial People's HospitalRecruiting
- The Fourth Hospital of Hebei Medical University, Hebei Tumor HospitalRecruiting
- The First Affiliates Hospital of Ha'erbin UniversityRecruiting
- Henan Provincial People's HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Tongji Medical College of HUSTRecruiting
- Union Hospital Tongji Medical College Huazhong Univeristy of Science and TechnologyRecruiting
- Zhongnan Hospital of Wuhan UniversityRecruiting
- Hunan Cancer HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Jiangsu Province Hospital of Chinese MedicineRecruiting
- Jiangsu Provincial HospitalRecruiting
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Northern Jiangsu People's HospitalRecruiting
- The Second Hospital of Jilin UniversityRecruiting
- Liaoning Cancer Hospital & InstituteRecruiting
- Qilu Hospital of Shandong UniversityRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- LongHua Hospital Shanghai University of Traditional Chinese MedicineRecruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)Recruiting
- The First Affiliatied Hospital Zhejiang University School of MedicineRecruiting
- The Second Affiliated Hospital Zhejiang Univerisity of MedicineRecruiting
- Huamei Hospital, University of Chinese Academy of SciencesRecruiting
- Ningbo Medical Center Lihuili HospitalRecruiting
- The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMURecruiting
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Huaier Granule + Conventional Treatment/visit
Conventional Treatment/visit
Huaier Granule: oral administration, 20g each time, 3 times a day. The starting time of Huaier granule: from the beginning of adjuvant therapy to the end of adjuvant therapy, and within 60 days after the end of adjuvant therapy is also acceptable. Conventional Treatment/visit:The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.
Conventional Treatment/visit:The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.