Huaier Granule in Treating Women With Triple Negative Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Shandong University
Updated on 21 January 2021
platelet count
cancer
breast cancer
neutrophil count

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.

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.

Details
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

Eligibility

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
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