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

Recruiting now · Phase 4

Conditions studied: Carcinoma Breast, Triple-negative Breast Cancer, Invasive Ductal Carcinoma, Breast

In brief

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.

Key facts

Study ID

NCT04790305

Run by

Fudan University

People needed

1072

Starts

2021-06-18

Expected to finish

2028-07-28

Last updated by the study team

2024-06-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• The First Affiliated Hospital of USTC, Anhui Provincial Hospital — Hefei, Anhui, China (enrolling)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (enrolling)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• The Fourth Hospital of Hebei Medical University, Hebei Tumor Hospital — Shijiazhuang, Hebei, China (enrolling)
• The First Affiliates Hospital of Ha'erbin University — Harbin, Heilongjiang, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Tongji Medical College of HUST — Wuhan, Hubei, China (enrolling)
• Union Hospital Tongji Medical College Huazhong Univeristy of Science and Technology — Wuhan, Hubei, China (enrolling)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Jiangsu Province Hospital of Chinese Medicine — Nanjing, Jiangsu, China (enrolling)
• Jiangsu Provincial Hospital — Nanjing, Jiangsu, China (enrolling)
• Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (enrolling)
• The Second Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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