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Carcinoma BreastPhase 4NCT04790305

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

A Phase 4 study testing Huaier Granule in people with Carcinoma Breast and Triple-negative Breast Cancer, run by Fudan University at 34 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Huaier Granule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,072 participants
Where
34 sitesChina
Study dates
18 Jun 2021to 28 Jul 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhimin Shao, PhD contact

+86-18017312288

zhimingshao@yahoo.com

Liang Huang, PhD contact

+86-18121299334

fdhlyx@163.com

34 sites in 1 country

China34 sites, 34 recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality

    Xiang Wang

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin

    Yan Zhang

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Dongfang Li

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Enxiang Zhou

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Guobing Yin

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Xia Chen

    Recruiting

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong

    Qianjun Chen

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Kun Wang

    Recruiting

  • The First Affiliatied Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Peifen Fu

    Recruiting

  • The Second Affiliated Hospital Zhejiang Univerisity of Medicine

    Hangzhou, Zhejiang

    Yiding Chen

    Recruiting

  • The First Affiliates Hospital of Ha'erbin University

    Harbin, Heilongjiang

    Yi Zhou

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Jingjie Zhang

    Recruiting

  • The First Affiliated Hospital of USTC, Anhui Provincial Hospital

    Hefei, Anhui

    Xiaopeng Ma

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Qifeng Yang

    Recruiting

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu

    Chang Yao

    Recruiting

  • Jiangsu Provincial Hospital

    Nanjing, Jiangsu

    Shui Wang

    Recruiting

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

    Nanjing, Jiangsu

    Yongzhong Yao

    Recruiting

  • Huamei Hospital, University of Chinese Academy of Sciences

    Ningbo, Zhejiang

    Xujun Li

    Recruiting

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Weizhu Wu

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Haibo Wang

    Recruiting

  • LongHua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

    Sheng Liu

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Zhimin Shao, PhD, zhimingshao@yahoo.com

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

    Daqing Jiang

    Recruiting

  • The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital

    Shijiazhuang, Hebei

    Cuizhi Geng

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Jianxia Liu

    Recruiting

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

    Wenzhou, Zhejiang

    Ouchen Wang

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Yaojun Feng

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Yi Tu

    Recruiting

  • Tongji Medical College of HUST

    Wuhan, Hubei

    Xingrui Li

    Recruiting

  • Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology

    Wuhan, Hubei

    Tao Huang

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Gaosong Wu

    Recruiting

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

    Xi’an, Shanxi

    Shuqun Zhang

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu

    Deyuan Fu

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Hui Liu

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Huaier Granule
Keywords
Huaier Granule, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast, Adjuvant Treatment
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Ductal, Breast

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Huaier GranuleDrug

    Also called Z20000109（NMPA Approval Number）

    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.

Study groups in NCT04790305
Study groupRoleWhat they receive
Huaier Granule + Conventional Treatment/visitExperimentalHuaier 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.
Receives: Drug: Huaier Granule
Conventional Treatment/visitNo interventionConventional Treatment/visit：The postoperative adjuvant therapy and visit of TNBC are based on clinical routine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year rates of disease-free survival

    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.

    Measured: Start of treatment until 3-year follow-up

Secondary outcomes (8)

  1. 3-year rates of overall survival

    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.

    Measured: Start of treatment until 3-year follow-up

  2. 3-year rates of invasive-disease-free survival

    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.

    Measured: Start of treatment until 3-year follow-up

  3. 5-year rates of disease-free survival

    5-year rates of disease-free survival: The percentage of participants who have not occurred events described in the DFS definition within 5 years.

    Measured: Start of treatment until 5-year follow-up

  4. 5-year rates of overall survival

    5-year rates of overall survival: The percentage of participants who have not died from any cause within 5 years.

    Measured: Start of treatment until 5-year follow-up

  5. 5-year rates of invasive-disease-free survival

    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.

    Measured: Start of treatment until 5-year follow-up

  6. Changes in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire

    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).

    Measured: Up to 5 years since the start of treatment

  7. Incidence and severity of AE or SAE

    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.

    Measured: Start of treatment until 3 year after enrollment

  8. Incidence and severity of ADR，SUSAR or SADR

    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.

    Measured: Start of treatment until 3 year after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2021
  2. Study start18 Jun 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion28 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,072 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04790305
Sponsor's protocol ID
HE-202012
Status last verified
Jun 2024
First submitted
5 Mar 2021
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Huaier Granule in people with Carcinoma Breast and Triple-negative Breast Cancer, run by Fudan University at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhimin Shao, PhD (+86-18017312288, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year rates of disease-free survival (time frame: Start of treatment until 3-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04790305.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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