Triple Negative Breast Cancer Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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