Huaier Granule in Treating Women With Triple Negative Breast Cancer

  • participants needed
  • sponsor
    Shandong University
Updated on 21 January 2021
platelet count
breast cancer
neutrophil count



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.


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



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.


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.

Condition Breast Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment Huaier Granule
Clinical Study IdentifierNCT02615457
SponsorShandong University
Last Modified on21 January 2021


Yes No Not Sure

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 100109/L, absolute neutrophil count > 1.5109/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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note