breast cancer
Conditions
Interventions
experimental group:ES001
control group:Placebo
Sponsors
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, female; 2. The patients with primary breast cancer diagnosed by histopathology were stage II and stage III a [according to the TNM staging system of AJCC, 8th Edition 2017] after operation; 3. ECoG physical fitness score 0-1; 4.The functional level of major organs must conform to the following requirements: Neutrophils (ANC) = 1.5×109/L (with no use of growth factors within 14 days); Platelet count (PLT) = 100×109/L (with no correct treatment within 7 days ); Hemoglobin (Hb) = 90 g/L (with no correct treatment within 7 days ); Total bilirubin (TBIL) = 1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3×ULN; Urea nitrogen and creatinine = 1.5×ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); Cardiac color Doppler ultrasound: left ventricular ejection fraction (LVEF) = 50%; 6.The patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Inability to swallow, chronic diarrhea and intestinal obstruction, and having many factors that affect drug administration and absorption; 2.Cardiac insufficiency, including but not limited to congestive heart failure, transmural myocardial infarction, angina pectoris requiring medical treatment, clinically significant valvular disease and high-risk arrhythmia, or abnormal QTc in the ECG examination during the screening period (at rest, QTc > 450 ms in male or QTc > 470 ms in female after correction of ECG examination); 3.Previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 4.Patients with serious systemic infection or other serious diseases; 5.Patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants; 6.pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 7.patients not suitable for the study were judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| left ventricular ejection fraction;TnI;NTpro-BNP;Oxidized Lipids of blood; | — |
Countries
China
Contacts
Public ContactHuang Chuying
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Outcome results
None listed