Huaier Granule in Treating Women With Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02615457
• Other study ID #: HECT001
• Status: Recruiting
• Phase: Phase 4
• First received: November 17, 2015
• Last updated: November 24, 2015
• Start date: October 2015

Study information

• Verified date: November 2015
• Source: Shandong University
• Contact: Qifeng Yang, Professor
• Phone: +8618560085168
• Email: qifengy_sdu[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Shandong Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Qilu hospital of Shandong University	Ji'nan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 a signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 years	No
Secondary	Overall survival (OS)	Time from randomization to death from any cause, assessed up to 10 years.	Up to 10 years	No