Actively Recruiting
A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) and Abraxane400 mg in Breast Cancer Patients
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2025-07-31
28
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the bioequivalence of two forms of paclitaxel protein-bound particles for injectable suspension (albumin-bound) in patients with breast cancer. This randomized, open-label, two-period crossover Phase 1 study aims to compare the test product with the reference product Abraxane400 mg doses to determine if they have similar effects on the body. The study focuses on breast cancer patients who have specific treatment histories and meet defined health criteria. Participants will receive a single intravenous infusion of either 260 mg/m2 of the test paclitaxel protein-bound particles or 260 mg/m2 of Abraxane400 mg in separate periods. The study involves random assignment to one of these treatments and later crossover to the other, allowing each participant to receive both treatments in a controlled sequence. The intervention groups are monitored without masking, meaning both researchers and participants know which treatment is administered. Throughout the study, participants will be closely monitored for up to 72 hours after dosing to measure peak plasma concentration (Cmax), area under the plasma concentration versus time curve (AUC0-t and AUC0-1), and other pharmacokinetic parameters such as time to peak concentration and elimination half-life. Adverse events will be tracked for up to 6 months. Participants will undergo blood tests and other health assessments to monitor safety and drug behavior. The total duration of involvement will depend on the timing of the crossover and follow-up periods.
CONDITIONS
Brief Title
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects fully understand the study purpose, methods, and possible adverse reactions, volunteer, and sign informed consent
- Male and female participants aged 18 to 75 years
- Histopathology and/or cytology confirmed breast cancer with metastatic disease after chemotherapy failure or relapse within 6 months of adjuvant chemotherapy
- Meet treatment criteria per NCCN and CSCO guidelines for paclitaxel monotherapy
- ECOG performance status score of 2 or less
- Expected life span of at least 3 months
- Blood, liver, and kidney function tests within specified ranges
- No fertility plans and agree to use effective contraception for at least 6 months from consent to last dose
- Able to communicate well, understand, and comply with study requirements
You will not qualify if you...
- Severe allergy or hypersensitivity to paclitaxel or human albumin
- Serious diseases other than cancer, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood disorders
- Major surgery within 4 weeks before screening or planned during the study
- Pregnant or lactating females
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infection markers
- Use of other anti-tumor drugs or therapies within 4 weeks before first dose
- Significant ECG abnormalities or QTcF interval >470 ms
- Sensory or peripheral neuropathy grade 2 or higher
- Blood donation or significant blood loss (>400 mL) within 90 days before screening
- Use of drugs affecting CYP2C8 or CYP3A4 metabolism within 28 days before dosing
- Excessive alcohol use or inability to stop during study
- Smoking more than 5 cigarettes per day or inability to stop during study
- Clinically significant abnormal vital signs or lab results unsuitable for enrollment
- History of drug abuse within 6 months before screening
- Unresolved toxicity from prior anti-tumor drugs above grade 1 (except alopecia)
- Use of granulocyte-stimulating growth factor within 2 weeks before dosing
- Participation in another clinical trial within 1 month before screening
- Any other investigator-determined conditions making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 treatment periods with washout in between
Participants receive a single dose of either paclitaxel protein-bound particles for injectable suspension (albumin-bound) or Abraxane®, followed by crossover to the other treatment.
2 treatment visits and multiple follow-up visits within 72 hours after each dose
Duration - Up to 6 months
Participants are monitored for adverse events and safety up to 6 months after treatment.
Periodic safety assessments
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here