Effect of Huaier Granule on Adjuvant Treatment for High-risk Early-stage Triple-negative Breast Cancer
- Conditions
- Invasive Ductal Carcinoma, BreastCarcinoma BreastTriple-negative Breast Cancer
- Interventions
- Drug: Huaier Granule
- Registration Number
- NCT04790305
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Triple-negative breast cancer（TNBC） accounts for 10% to 20% of breast cancer. TNBC is more likely to show lymph node involvement at diagnosis, and biologically more aggressive. Women with TNBC have a higher rate of distant recurrence at early-stage and a worse 5-year prognosis than women of other molecular types. Although PARP inhibitors and immune checkpoint inhibitors are showing promise to patients with advanced TNBC, however, these targeted therapies and immunotherapy for TNBC can not increase the clinical benefits of early-stage patients.
As adjuvant therapy for hepatocellular carcinoma after curative liver resection, a multicentre study demonstrated a significant prolongation of RFS and reduced extrahepatic recurrence in Huaier group. Retrospective studies have shown that Huaier granules can improve the rates of disease-free survival（DFS） and overall survival（OS）, and reduce the incidence of adverse events among operable patients with TNBC.
In this study, 1072 high-risk early-stage triple-negative invasive ductal carcinoma participants (536 cases in the observation group and 536 cases in the control group) from 30 research centers will be included. The block randomization was adopted, participants will be randomly divided into the experimental group (Huaier granule plus conventional treatment/visit) and control group (conventional treatment/visit only). All participants will be followed up for 5 years, including 2-year treatment follow-up and 3-year survival follow-up. During the treatment period, the participants will be followed up every 3 months, and the survival follow-up period will be followed up every 6 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1072
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Huaier Granule + Conventional Treatment/visit Huaier Granule 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.
- Primary Outcome Measures
Name Time Method 3-year rates of disease-free survival Start of treatment until 3-year follow-up Disease-free survival (DFS)：The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, ipsilateral ductal carcinoma in situ, contralateral ductal carcinoma in situ, second primary invasive carcinoma (except breast cancer).
3-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 3 years.
- Secondary Outcome Measures
Name Time Method 5-year rates of disease-free survival Start of treatment until 5-year follow-up 5-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 5 years.
3-year rates of overall survival Start of treatment until 3-year follow-up Overall survival (OS): The time from randomization until the date of death from any cause.
3-year rates of overall survival: The percentage of participants who have not died from any cause within 3 years.5-year rates of overall survival Start of treatment until 5-year follow-up 5-year rates of overall survival: The percentage of participants who have not died from any cause within 5 years.
5-year rates of invasive-disease-free survival Start of treatment until 5-year follow-up 5-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 5 years.
3-year rates of invasive-disease-free survival Start of treatment until 3-year follow-up Invasive-disease-free survival (iDFS): The time from randomization until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, local recurrence, distant metastasis, death from any cause, contralateral invasive breast cancer, second primary invasive carcinoma (except breast cancer).
3-year rates of invasive-disease-free survival: The percentage of participants who have not occurred events described in the iDFS definition within 3 years.Incidence and severity of AE or SAE Start of treatment until 3 year after enrollment AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
SAE: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.Changes in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Up to 5 years since the start of treatment Quality of Life (QOL) will be measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). The scope of each domain is 0 to 100. Higher scores in the functional and general health areas indicate better functional status and quality of life, and higher scores in the symptomatic areas indicate more symptoms or problems (poorer quality of life).
Incidence and severity of ADR，SUSAR or SADR Start of treatment until 3 year after enrollment All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. A SADR is a serious ADR according to the above criteria of SAE. A SUSAR is an unexpected SADR.
Trial Locations
- Locations (34)
Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology
🇨🇳Wuhan, Hubei, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
🇨🇳Xi'an, Shanxi, China
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, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital
🇨🇳Shijia Zhuang, Hebei, China
The First Affiliates Hospital of Ha'erbin University
🇨🇳Ha'erbin, Heilongjiang, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, 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
LongHua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
The First School of Medicine, School of Information and Engineering,the First Affiliated Hospital of WMU
🇨🇳Wenzhou, Zhejiang, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Second Hospital of Jilin University
🇨🇳Chang chun, Jilin, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, 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
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China