breast cancer
Conditions
Interventions
Therapeutic Drug Monitoring Group:Monitoring of docetaxel concentration
Control group:Dosage calculation of docetaxel based on BSA
Sponsors
The International Peace Maternity and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1)Patients with breast cancer radical operation received adjuvant chemotherapy; No recurrence and metastasis occured. (2)Docetaxel combined chemotherapy regimen:Docetaxel/cyclophosphamide. (3)Age 18-70 (4)ECOG score: 0-1 (5)Estimated survival period = 3 months (6)Normal function of main organs and meeting the following criteria:? routine blood test:HB= 90 g/L(No blood transfusion within 14 days);ANC =1.5×109/L;PLT =100×109/L;? Biochemical examination:TBIL =1.5×ULN(Upper limit of normal value);ALT,AST = 3×ULN;Cr = 1×ULN,Endogenous creatinine clearance>50 ml/min(Cockcroft-Gault); (7)The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1)Poor treatment compliance; (2)Vital organs basic diseases:Severe organ dysfunction (heart, lung, liver, kidney); LEVF150/90mmHgmyocardial infarction or cerebrovascular accident)unsatisfactory blood glucose control;severe hypertension; (3)Allergies to taxanes and excipients; (4)Serious or uncontrolled infection; (5)Persons who had a history of abuse of psychotropic substances and were unable to abstain or had a history of mental disorders; (6)Pregnant or lactating women; (7)Patients with recurrence and metastasis of breast cancer after radical mastectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| white blood cell;platelet;Alanine aminotransferase;Aspartate aminotransferase;total bilirubin;disease-free survival; | — |
Countries
China
Contacts
Public ContactZhang Xiaoqing
The International Peace Maternity and Child Health Hospital
Outcome results
None listed