Breast cancer
Conditions
Interventions
Group 1:The first cycle intravenous infusion of the test preparation
the second cycle intravenous infusion of reference preparation
Group 2:The first cycle intravenous infusion of reference preparation
the second cycle intravenous infusion of the test preparation
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; 2) to be able to complete the study in accordance with the requirements of the trial program; 3) Childbearing age subjects (including partners) within 6 months after the start of the trial no pregnancy plan and voluntary take effective contraceptive measures. 4) Aged 18-65 years male or female; 5) advanced breast cancer or investigators who have been diagnosed by histology, cytology, or imaging, who are considered to be suitable for injection of paclitaxel (albumin-binding) monotherapy with anti-tumor therapy; 6) ECOG score 0 to 1; 7) Expected survival period = 3 months; 8) laboratory tests: hemoglobin = 90g/dL (14 days without blood transfusion), neutrophil count =1.5×10^9/L, platelet count =100×10^9/L, alanine aminotransferase (ALT), day gate (TBI), creatinine (Cr) =1.5 times, and the ratio of total bilirubin (TBIL), creatinine (Cr) =1.5 times Normal upper limit and serum creatinine clearance rate = 60ml/min Calculation formula: Ccr: (140 - age) × body weight (kg)/0.818×Scr (umol/L), female ×0.85.
Exclusion criteria
Exclusion criteria: 1) Radiotherapy, chemotherapy, immunization, endocrine therapy and treatment of residual effects were received within 4 weeks prior to the use of the study drug; 2) allergies (not including mild asymptomatic seasonal allergies), or known (including suspected) to the active ingredient paclitaxel or its excipients, albumin allergy; 3) Surgery or fractures have been received within 4 weeks prior to the use of the study drug, or surgery is planned for the duration of the study; 4) with bleeding tendency or are receiving thrombolytic or anticoagulant therapy or in the use of research drugs within 3 months before the blood donation, blood loss greater than 450ml; 5) have a history of drug and / or alcohol abuse (ie, men drink more than 28 standard units per week, women drink more than 21 standard units per week [1 standard unit with 14g alcohol, such as 360mL beer or 45mL alcohol 40% Wine or 150mL wine]); 6) cerebrovascular accident or a history of transient ischemic attack; 7) According to the investigator, there is a concomitant disease (severe diabetes or thyroid disease) that seriously compromises the safety of the subject or affects the subject to complete the trial; 8) have a clear history of neurological or mental disorders (including epilepsy and dementia); 9) Substrates used with CYP2C8 or / and CYP3A4 enzymes, strong inducers or strong inhibitors (including ketoconazole and other imidazole antifungal agents, verapamil, stabilized, quino) were used within 28 days prior to the use of the study drug Diazepam, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17-alpha diethylstilbestrol, retinoic acid, quercetin, etc.); 10) 2 weeks before the test to accept granulocyte stimulating growth factor therapy; 11) 2 weeks before the test used a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise and other factors; 12) used other research drugs within 3 months prior to the use of the study drug, or participated in a drug clinical trial; 13) peripheral neuropathy = 2 level; 14) had myocardial infarction (6 months before the trial), severe or unstable angina, coronary artery or peripheral arterial bypass, NYHA 3 ~ 4 heart failure. Can not control the high blood pressure, the researchers believe that clinical significance of arrhythmia or ECG abnormalities; 15) viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, Treponema pallidum antibody screening positive; 16) female subjects in the screening period or during the test process is in lactation or serum pregnancy results were positive, except for malignant tumors due to the pathological state of the results were positive; 17) alcohol and drug screening positive; 18) Subjects may not be able to complete this study or researchers who believe that they should not be included for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed