Breast cancer
Conditions
Interventions
T-R group:In the first cycle, 12 subjects were intravenously given taxol for injection (albumin-binding type), 260mg/m^2, 30±3min, 3 weeks later, cross-administered, reference preparation for injectio
R-T group:In the first cycle, 12 subjects received intravenous infusion of reference preparation paclitaxel (albumin-binding type) (Abraxane) 260mg/m^2 for injection for 30±3min. 3 weeks later, the dr
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test plan; 2. The patient (including partner) has no pregnancy plan and voluntarily takes effective contraceptive measures from 2 weeks before self-medication to 6 months after the last test drug administration; 3. Aged 18-65 years (including boundary values), no gender limit; 4. Patients with breast cancer confirmed by histology, cytology or imaging and meeting the following conditions: metastatic breast cancer with failure of combination chemotherapy or recurrence within 6 months after adjuvant chemotherapy; 5. ECOG score 0~1; 6. Expected survival >=3 months; 7. Laboratory examination: (1) Hemoglobin (Hb) >=90g/L (no transfusion within 14 days), white blood cell count (WBC) >=3.0x10^9L, neutrophil count (ANC) >=1.5x10^9/L, platelet count (PLT) >=100x10^9/L; (2) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60ml/min [Calculation formula: Ccr: (140- age) x body weight (kg) /0.818xScr (umol/L), female x0.85].
Exclusion criteria
Exclusion criteria: 1. (Inquiry) Allergic constitution (excluding mild asymptomatic seasonal allergy), or known (including suspected) allergic or specific reaction to the active ingredient paclitaxel or its exciples, albumin; 2. (Consultation) Patients who received radiotherapy, chemotherapy, immunotherapy or endocrine therapy within 4 weeks prior to the use of the experimental drug and still have residual effects of treatment; 3. (Consultation) Use of substrates, inducers or inhibitors of CYP2C8 or CYP3A4 enzymes (including but not limited to ketoconazole and other imidazole antifungals, verapamil, Diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17-a estradiol, tretinoin, quercetin, erythromycin, fluoxetine, gefilozil, cimetidine, Ritonavir, Saquinavir, indinavir and nelfinavir, rifampicin, carbamazepine, phenytoin, Faevieran, Nevira equality); 4. Patients who received granulocyte stimulating growth factor treatment within 2 weeks before screening; 5. (Consultation) Peripheral neuropathy >= grade 2; 6. (For inquiry) Patients with serious cardiovascular and cerebrovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric diseases that researchers consider unsuitable for inclusion; 7. (Consultation) Patients with a clear history of neurological or psychiatric disorders (including epilepsy and dementia); 8. (Consultation) Patients with cerebrovascular accident or transient ischemic attack history; 9. History of myocardial infarction (within 6 months prior to the trial), severe or unstable angina, coronary or peripheral artery bypass grafting, or New York Heart Association Class 3-4 heart failure; 10. (Consultation) Patients who have undergone surgery or suffered a fracture within 4 weeks prior to the use of the experimental drug, or who plan to undergo surgery during the study period; 11. (Consultation) Patients who are prone to bleeding or are receiving thrombolytic or anticoagulant therapy or who have donated blood and lost more than 400ml of blood within 3 months prior to the use of the test drug; 12. (Consultation) A history of drug and/or alcohol abuse (i.e., more than 28 standard units per week for men and 21 standard units per week for women [1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL 40% spirits or 150mL wine]); 13. (Consultation) Used special diet (food affecting CYP3A4 enzyme or CYP2C8 enzyme, such as grapefruit, grapefruit, mango, etc.), strenuous exercise or other factors that may affect drug absorption, distribution, metabolism, excretion, etc., within 1 week before the use of the experimental drug; 14. Patients with bilateral breast cancer confirmed by histology, cytology or imaging; 15. Concurrent malignant neoplasms other than breast cancer, other than basal cell carcinoma or squamous cell carcinoma of the skin, which have been surgically resected within 5 years; 16. Poorly controlled hypertension (systolic blood pressure > 160 MMHG and/or diastolic blood pressure > 100mmHg under regular medication control); 17. Patients whose 12-lead ECG abnormalities were considered clinically significant and unsuitable for inclusion by the investigator; 18. Those who test positive for alcohol and drug abuse (other than regular use of painkillers for cancer pain); 19. HBsAg positive while HBV DNA positive test; Hepatitis C antibody positive and HCVRNA positive test; Hiv-positive patients; Patients with positive a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration;AUC0-4 (Area under the curve from the time of administration to the lowest detectable blood concentration);AUC0-8 (Area under curve from drug administration to time extrapolated to infinity);Residual area percentage, AUC_%Extrap; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach peak concentration;Time to reach peak concentration;Eliminate terminal half-life, t1/2; | — |
Countries
China
Contacts
Public ContactYang Guoping, Ding Boni
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed