Breast cancer
Conditions
Interventions
T-R group:paclitaxel for injection in the first cycle (albumin-bound type))
Second cycle Abraxane
R-T group:First Cycle Abraxane
2nd cycle paclitaxel for injection (albumin-bound type)
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial; 2. Able to complete the study in accordance with the requirements of the test protocol; 3. Female subjects of childbearing potential have no pregnancy plan and voluntarily take effective contraceptive measures during the whole trial period and within 6 months after the last dose; Male subjects (whose partner is of childbearing potential) had no fertility plans and voluntarily used effective contraception throughout the trial and for 3 months after the last dose 4. Male or female subjects aged 18~70 years old; 5. Patients with breast cancer confirmed by histopathological and/or cytology, and meet one of the following conditions: (1) metastatic breast cancer that has failed combination chemotherapy or breast cancer that has recurred within 6 months after adjuvant chemotherapy, prior treatment should include anthracyclines, unless there is a clinical contraindication; (2) The investigator judged that the subject was suitable for nab-paclitaxel treatment with reference to the treatment criteria (NCCN guidelines and CSCO guidelines - breast cancer); 6. ECOG PS score 0~1 points; 7. Estimated survival >=3 months; 8. Have good hematopoiesis and organ function before the first dose, and the laboratory test values meet the following requirements (no blood transfusion or use of component blood or hematopoietic growth factors within 14 days before screening): hemoglobin >=90 g/dL, neutrophil count >= 1.5×10^9/L, platelet count >= 100×10^9/L, alanine aminotransferase (ALT), aspartate aminotransferase (AST) =60 mL/min [calculated formula: Ccr=(140-age)× body weight (kg)/0.818×Scr(µmol/L), female×0.85.
Exclusion criteria
Exclusion criteria: 1. Radiotherapy, chemotherapy, immunology and endocrine therapy within 4 weeks before the use of the study drug, and there is still residual treatment effect; 2. Allergies (multiple drug and food allergies), or allergy to the active ingredient paclitaxel and its excipients and albumin; 3. Surgery or fracture within 4 weeks prior to the use of study drug, or planned surgery during the study; 4. Have a history of alcohol consumption (more than 14 units of alcohol per week within 6 months prior to the first dose: 1 unit = 285 ml of beer, or 25 ml of spirits, or 100 ml of wine), drug abuse (use of narcotic drugs or psychotropic substances for non-medical purposes), or a history of drug addiction, smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to quit smoking and alcohol during the period between signing the ICF and completing the bioequivalence study; 5. Has bleeding tendency, is receiving thrombolytic therapy or anticoagulant therapy, or has donated or lost = 450 ml of blood within 3 months prior to the use of study drug; 6. Have a clear history of neurological or psychiatric disorders (including epilepsy and dementia); 7. History of cerebrovascular accident or transient ischemic attack; 8. Concomitant diseases (severe diabetes mellitus or thyroid disease) that may seriously endanger the safety of the subject or affect his or her completion of the study in the judgment of the investigator; 9. History of myocardial infarction (within 6 months prior to screening), severe or unstable angina, coronary or peripheral artery bypass grafting, and NYHA grade 3-4 heart failure. Uncontrolled hypertension (e.g., blood pressure >160/100 mmHg despite regular medication control), cardiac arrhythmias, or abnormal and clinically significant electrocardiogram (ECG) in the opinion of the investigator; 10. > = Grade 2 peripheral neuropathy; 11. Have taken any drugs (inducers or inhibitors of CYP2C8 and/or CYP3A4) that may affect the activity of liver drug enzymes within 28 days prior to the use of the study drug (including but not limited to: ketoconazole, other imidazole antifungals, diazepam, quinidine, dexamethasone, cyclosporine, teniposide, etoposide, vincristine, testosterone, 17a-ethinylestradiol, tretinoin, quercetin, etc.); 12. Subject has eaten a special diet (consumption of foods that affect the activity of CYP3A4 or CYP2C8 enzymes, such as grapefruit, grapefruit, mango, etc.), strenuous exercise, or other factors that may affect the absorption, distribution, metabolism and excretion of the drug within 48 hours before taking the study drug; 13. Participation in other clinical trials or receipt of investigational drugs/devices within 4 weeks prior to the first dose (except for observational clinical trials); 14. Female subjects with positive test results during the screening period or during the study, positive during pregnancy or lactation, except for positive results in pathological states caused by malignant tumors; 15. Viral hepatitis (including hepatitis B (hepatitis B surface antigen (HBsAg positive, HBV DNA positive) and hepatitis C (hepatitis C antibody positive, HCV RNA positive)), HIV antibody, or active syphilis infection; 16. Positive urine test or alcohol screen (excluding clinical use of narcotic drugs); 17. Subject may not be able to complete the study for other reasons, or the investigator believes that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration;Area under the plasma concentration - time curve from time 0 to the last time point with quantifiable sample ;Area under the plasma concentration - time curve from time 0 to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum plasma concentration;Terminal half-life;Terminal elimination rate constant;Clearance;Apparent volume of distribution during the terminal elimination phase;Safety (symptoms and physical examination, clinical laboratory findings (blood routine, blood biochemistry, urinalysis, etc.), vital signs, ECG); | — |
Countries
China
Contacts
Public ContactMeili Sun; Qing Wen
Jinan Central Hospital
Outcome results
None listed