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RecruitingNCT02615457Updated Nov 26, 2015

Huaier Granule in Treating Women With Triple Negative Breast Cancer

A Phase 4 interventional study of Huaier Granule in Triple Negative Breast Cancer, sponsored by Shandong University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-26.

Sponsored by Shandong University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

RATIONALE:

Huaier (Trametes robiniophila Murr) is a traditional Chinese medicine, which has been widely used in China for many years. The investigators previous study has reported that Huaier could exert great inhibitory effects on breast cancer cells both in vitro and in vivo.

PURPOSE:

To evaluate the efficacy and safety of Huaier Granule in treating women who have triple negative breast cancer that has been surgically removed.

Read the detailed description

OBJECTIVES:

Compare the disease-free survival (DFS) and overall survival (OS) of patients with triple negative breast cancer who are randomized to adjuvant Huaier Granule group vs. those randomized to Blank-control group.

OUTLINE:

Patients are randomized to the following one of two treatment groups and are followed annually.

Arm I: Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed.

Arm II: Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.

02

Conditions studied

  • Triple Negative Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age: ≥ 18 and ≤ 75 years, female;
  • Triple negative breast cancer has been surgically removed;
  • The triple negative breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);
  • Not receiving any preoperative anticancer drugs;
  • The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \< 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 1.5 ULN;
  • Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g/l, platelet count ≥ 100×109/L, absolute neutrophil count > 1.5×109/L;
  • The expected survival time ≥ 6 months;
  • The subjects volunteer to sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients with stage IV breast cancer;
  • Triple negative breast cancer was not surgically removed;
  • Non-triple negative breast cancer patients confirmed by pathological examination and Immunohistochemistry (IHC);
  • Pregnant or lactating women;
  • Those with active bleeding due to various reasons;
  • Those with HIV infection or AIDS-associated diseases;
  • Those with severe acute and chronic diseases;
  • Those with severe diabetes;
  • Those with serious infectious diseases;
  • Those who can not take drugs by oral route;
  • Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
  • Conditions that are considered not suitable for this study investigators
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Arm I

    Patients taking Huaier Granule for adjuvant treatment after the triple negative breast cancer has been surgically removed. The Huaier Granule (Qidong Gaitianli Medicines Co., Ltd.) should be given orally from the 3rd day after surgery up to 5 years after surgery or until study termination.

    Drug: Huaier Granule

  • No intervention
    Arm II

    Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.

Interventions

  • DrugHuaier Granule

    Huaier Granule was given orally, 20 g tid for 5 years.

06

What researchers measure

Primary outcomes

  1. Disease free survival (DFS)

    Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years.

    Time frame: Up to 10 years

Secondary outcomes

  1. Overall survival (OS)

    Time from randomization to death from any cause, assessed up to 10 years.

    Time frame: Up to 10 years

07

Study locations

1 of 1 sites recruiting
  • Qilu hospital of Shandong University
    Ji'nan, Shandong 250012, China
    • Qifeng Yang, Professor · Contact · +86 18560085168
    Recruiting
08

References and documents

Publications

  • Wang X, Qi W, Li Y, Zhang N, Dong L, Sun M, Cun J, Zhang Y, Lv S, Yang Q. Huaier Extract Induces Autophagic Cell Death by Inhibiting the mTOR/S6K Pathway in Breast Cancer Cells. PLoS One. 2015 Jul 2;10(7):e0131771. doi: 10.1371/journal.pone.0131771. eCollection 2015. PubMed 26134510 ↗
  • Song X, Li Y, Zhang H, Yang Q. The anticancer effect of Huaier (Review). Oncol Rep. 2015 Jul;34(1):12-21. doi: 10.3892/or.2015.3950. Epub 2015 May 5. PubMed 25955759 ↗
  • Kong X, Ding X, Yang Q. Identification of multi-target effects of Huaier aqueous extract via microarray profiling in triple-negative breast cancer cells. Int J Oncol. 2015 May;46(5):2047-56. doi: 10.3892/ijo.2015.2932. Epub 2015 Mar 17. PubMed 25826742 ↗
  • Wang X, Zhang N, Huo Q, Sun M, Dong L, Zhang Y, Xu G, Yang Q. Huaier aqueous extract inhibits stem-like characteristics of MCF7 breast cancer cells via inactivation of hedgehog pathway. Tumour Biol. 2014 Nov;35(11):10805-13. doi: 10.1007/s13277-014-2390-2. Epub 2014 Jul 31. PubMed 25077927 ↗
  • Wang X, Zhang N, Huo Q, Sun M, Lv S, Yang Q. Huaier aqueous extract suppresses human breast cancer cell proliferation through inhibition of estrogen receptor alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20. PubMed 23686317 ↗
  • Wang X, Zhang N, Huo Q, Yang Q. Anti-angiogenic and antitumor activities of Huaier aqueous extract. Oncol Rep. 2012 Oct;28(4):1167-75. doi: 10.3892/or.2012.1961. Epub 2012 Aug 8. PubMed 22895629 ↗
  • Zhang N, Kong X, Yan S, Yuan C, Yang Q. Huaier aqueous extract inhibits proliferation of breast cancer cells by inducing apoptosis. Cancer Sci. 2010 Nov;101(11):2375-83. doi: 10.1111/j.1349-7006.2010.01680.x. PubMed 20718753 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02615457
Lead sponsor
Shandong University
Responsible party
Qifeng Yang (Professor, Shandong University) — Principal investigator
First posted
Nov 26, 2015
Start date
Oct 2015
Primary completion
Oct 2025 (estimated)
Last update
Nov 26, 2015

Study contacts

Qifeng Yang, Professor
Contact
qifengy_sdu@163.com
+8618560085168
Ning Zhang, Resident
Contact
zhangning0816@163.com
+8618560085950

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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