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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Huaier Granule
DrugThe 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.
Treatment groups
1,072 Participants
are divided into 2 treatment groupsGroup A: Huaier Granule + Conventional Treatment/visitExperimental treatment 1 intervention
Group B: Conventional Treatment/visitNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
Start of treatment until 3-year follow-upSecondary outcomes
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.
Time frame
Start of treatment until 3-year follow-up2
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.
Time frame
Start of treatment until 3-year follow-up3
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.
Time frame
Start of treatment until 5-year follow-up4
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.
Time frame
Start of treatment until 5-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov