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Huaier Granule in Treating Women With Triple Negative Breast Cancer

Primary Purpose

Triple Negative Breast Cancer

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huaier Granule
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Qilu hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I

Arm II

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival (OS)
Time from randomization to death from any cause, assessed up to 10 years.

Full Information

First Posted
November 17, 2015
Last Updated
November 24, 2015
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02615457
Brief Title
Huaier Granule in Treating Women With Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II
Arm Type
No Intervention
Arm Description
Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.
Intervention Type
Drug
Intervention Name(s)
Huaier Granule
Intervention Description
Huaier Granule was given orally, 20 g tid for 5 years.
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
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 Outcome Measure Information:
Title
Overall survival (OS)
Description
Time from randomization to death from any cause, assessed up to 10 years.
Time Frame
Up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qifeng Yang, Professor
Phone
+8618560085168
Email
qifengy_sdu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Zhang, Resident
Phone
+8618560085950
Email
zhangning0816@163.com
Facility Information:
Facility Name
Qilu hospital of Shandong University
City
Ji'nan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifeng Yang, Professor
Phone
+86 18560085168

12. IPD Sharing Statement

Citations:
PubMed Identifier
26134510
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.
Results Reference
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PubMed Identifier
25955759
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.
Results Reference
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PubMed Identifier
25826742
Citation
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.
Results Reference
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PubMed Identifier
25077927
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.
Results Reference
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PubMed Identifier
23686317
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 alpha signaling. Int J Oncol. 2013 Jul;43(1):321-8. doi: 10.3892/ijo.2013.1947. Epub 2013 May 20.
Results Reference
background
PubMed Identifier
22895629
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.
Results Reference
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PubMed Identifier
20718753
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.
Results Reference
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Huaier Granule in Treating Women With Triple Negative Breast Cancer

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