A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane® in Breast Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• 5\) The expecting life span ≥ 3months;

• 6\) The results of blood, liver and kidney function tests are within the following ranges: Absolute neutrophil counts (ANC) ≥ 1.5×10\^9/L Platelets (PLT) ≥ 100×10\^9/L Hemoglobin (Hb) ≥ 90 g/L Total bilirubin (TBIL) ≤ 1.5×ULN Alanine transaminase (ALT), Aspartate aminotransferase (AST)≤×ULN (for patients with liver metastasis, ≤ 5×ULN) Creatinine clearance (CrCL)≥ 60 mL/min

• 7\) The subject has no fertility plan (including sperm donation and egg donation) for at least 6 months from the signing of informed consent to the last dose and voluntarily takes non-drug effective contraceptive measures;

• 8\) Subjects can communicate well with the investigators, understand and comply with the requirements of the study.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Clinical Trials Information Group officer
ctr-contact@cspc.cn
86-0311-69085587
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2026-02-25
Participants
Target number of participants: 28
Treatments
Experimental: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
The subjects randomly reveived single dose of 260 mg/m\^2 of paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Experimental: Abraxane®
The subjects randomly reveived single dose of 260 mg/m\^2 of Abraxane®
Related Therapeutic Areas
Sponsors
Leads: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

This content was sourced from clinicaltrials.gov