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.
Age
18–75
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Huaier Granule in Treating Women With Triple Negative Breast Cancer
