The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer patients.
1) Subjects fully understand the purpose, nature, method and possible adverse reactions of the study, volunteer as subjects, and sign informed consent prior to the commencement of any study procedure;
2) Male and female, ages 18-75 years both inclusive;
3) Subjects with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ①Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated; ②This treatment criteria (NCCN guidelines and CSCO guidelines - Breast cancer) is used to determine whether the subjects are suitable for paclitaxel for injection (albumin-bound) monotherapy. ③Subjects received standard treatment without conditions and were judged to benefit from injectable paclitaxel (albumin-binding) monotherapy;
4) ECOG Score ≤ 2 points;
1) A severe allergy or hypersensitivity to paclitaxel or human albumin;
2) In addition to cancer, have any other serious liver, kidney/genitourinary, gastrointestinal (e.g., abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood (e.g., bleeding diathymia or clotting disorders) diseases Patients with a known or present history of the disease who are deemed unsuitable for enrollment by the investigators;
3) Those who had undergone major surgery within 4 weeks prior to screening, or planned to undergo major surgery during the study period;
4) Pregnant or lactating female subjects;
Crossover
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
DrugIV infusion, 260 mg/m\^2
Abraxane®
DrugIV infusion, 260 mg/m\^2
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax) of total and unbound paclitaxel
Area under the plasma concentration versus time curve AUC0-t
Evaluation of Area under the plasma concentration versus time curve AUC0-t of total and unbound paclitaxel
Area under the plasma concentration versus time curve AUC0-∞
Evaluation of Area under the plasma concentration versus time curve AUC0-∞ of total and unbound paclitaxel
Time to peak Plasma Concentration (Tmax)
The Tmax of total and unbound paclitaxel
Elimination of half-life (t1/2)
The t1/2of total and unbound paclitaxel
Incidence of Adverse Events
Collection of adverse events
Click on the lead sponsor to view all of their trials.
