Huaier Granule in Treating Women With Triple Negative Breast Cancer
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedNovember 26, 2015
November 1, 2015
10 years
November 17, 2015
November 24, 2015
Conditions
Outcome Measures
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.
Up to 10 years
Secondary Outcomes (1)
Overall survival (OS)
Up to 10 years
Study Arms (2)
Arm I
EXPERIMENTALPatients 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.
Arm II
NO INTERVENTIONPatients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Qilu hospital of Shandong University
Ji'nan, Shandong, 250012, China
Related Publications (7)
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.
PMID: 26134510BACKGROUNDSong 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.
PMID: 25955759BACKGROUNDKong 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.
PMID: 25826742BACKGROUNDWang 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.
PMID: 25077927BACKGROUNDWang 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.
PMID: 23686317BACKGROUNDWang 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.
PMID: 22895629BACKGROUNDZhang 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.
PMID: 20718753BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 26, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2025
Last Updated
November 26, 2015
Record last verified: 2015-11