Huaier Granule in Treating Women With Triple Negative Breast Cancer

Study Overview
=================
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.

Conditions
-----------------
Triple Negative Breast Cancer

Intervention / Treatment
-----------------
* Drug: Huaier Granule


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Huaier Granule was given orally, 20 g tid for 5 years.<br>|
| No Intervention: Arm II<br>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 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 from randomization to death from any cause, assessed up to 10 years. | Up to 10 years |