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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Huaier Granule was given orally, 20 g tid for 5 years.
Qilu hospital of Shandong University
Ji'nan, Shandong, China
RECRUITINGDisease 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.
Time frame: Up to 10 years
Overall survival (OS)
Time from randomization to death from any cause, assessed up to 10 years.
Time frame: Up to 10 years
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