This study was a multicenter, randomized, open, single-dose, two-cycle, two-cross-dosing human bioequivalence trial designed to evaluate the bioequivalence of tested and reference preparations in breast cancer subjects.
Subjects voluntarily participate in the study and sign the informed consent forms (ICFs);
Patients with breast cancer confirmed by histopathology and/or cytology who meet one of the following conditions: ① with metastatic breast cancer that does not respond to combination chemotherapy or recurrent breast cancer within 6 months after adjuvant chemotherapy, and an anthracycline anticancer drug should be used in the previous chemotherapy unless clinically contraindicated; ② investigators determine that subjects are candidates for albumin-bound paclitaxel by reference to the treatment guidelines (NCCN Guidelines and CSCO Guidelines for breast cancer);
Aged 18-75 years old (both inclusive), males or females; body mass index (BMI) ≥17 (BMI = weight (kg)/height (m2));
The ECOG score is 0-2;
Subjects with allergic constitution (excluding mild asymptomatic seasonal allergies), or who are known (or suspected) to be allergic to or have a specific reaction to the active ingredient paclitaxel or excipients, albumin;
Subjects who have received radiotherapy, chemotherapy, immunotherapy and endocrinotherapy within 4 weeks before the administration of the investigational drug and still respond to the treatment;
Subjects who have suffered from serious illness of cardio-cerebral vascular system, lung, liver, kidney, gastrointestinal tract, endocrine system, immune system, skin, musculoskeletal system and nervous system or psychiatric disorders within 3 months before screening and are considered unsuitable for enrollment by the investigator;
Subjects who have undergone major surgery or suffered from fracture within 4 weeks prior to screening, or plan to undergo major surgery during the study;
Crossover
T, 260 mg/m2, paclitaxel for injection (albumin-bound)
DrugT, 260 mg/m2, paclitaxel for injection (albumin-bound)
R, 260 mg/m2, paclitaxel for injection (albumin bound).
DrugR, 260 mg/m2, paclitaxel for injection (albumin bound).
Maximum observed concentration of paclitaxel (Cmax)
Area under the concentration-time curve from time zero to infinite time of paclitaxel (AUC 0-inf)
Area under the concentration-time curve from time zero to the last time of paclitaxel (AUC 0-t)
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Sichuan Huiyu Pharmaceutical Co., Ltd
Lead sponsor
The First Hospital of Jilin University
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Chongqing Traditional Chinese Medicine Hospital
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
Qianfoshan Hospital
Collaborator
