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NCT04790305

PHASE4

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: Effect of Huaier Granule on Postoperative Adjuvant Treatment for High-risk Early-stage Triple-negative Invasive Ductal Carcinoma: a Prospective, Multicenter, Randomized, Controlled, Open-label Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1072

Start Date

2021-06-18

Completion Date

2028-07-28

Last Updated

2024-06-27

Healthy Volunteers

Conditions

Carcinoma Breast Triple-negative Breast Cancer Invasive Ductal Carcinoma, Breast

Interventions

DRUG

Huaier Granule

The subjects in the experimental group will be treated with Huaier Granule continuously for 2 years or until the disease progressed, intolerable toxicity, withdrawal of informed consent form or died for any reason.

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.

Locations (34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The First Affiliated Hospital of USTC, Anhui Provincial Hospital

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital

Shijiazhuang, Hebei, China

The First Affiliates Hospital of Ha'erbin University

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Medical College of HUST

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Jiangsu Provincial Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

LongHua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

Xi’an, Shanxi, China

The First Affiliatied Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang Univerisity of Medicine

Hangzhou, Zhejiang, China

Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

Fudan University Shanghai Cancer Center

Shanghai, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (34)