Huaier Granule in Treating Women With Triple Negative Breast Cancer

November 24, 2015 updated by: Qifeng Yang, Shandong University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Ji'nan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital Of Shandong University
        • Contact:
          • Qifeng Yang, Professor
          • Phone Number: +86 18560085168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Huaier Granule was given orally, 20 g tid for 5 years.
No Intervention: Arm II
Patients not taking Huaier Granule after the triple negative breast cancer has been surgically removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: Up to 10 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 10 years
Time from randomization to death from any cause, assessed up to 10 years.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Estimate)

November 26, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HECT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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