Actively Recruiting
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2025-07-31
28
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 and voluntarily sign informed consent before any study procedure
- Male and female, ages 18 to 75 years inclusive
- Breast cancer confirmed by histopathology and/or cytology with metastatic disease after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy
- Prior therapy should have included an anthracycline unless clinically contraindicated
- Subjects suitable for paclitaxel (albumin-bound) monotherapy based on guidelines and judged to benefit from this treatment
- ECOG performance score of 2 or less
- Expected life span of at least 3 months
- Blood, liver, and kidney function within specified ranges including ANC 1.5�d7 10^9/L, platelets 100�d7 10^9/L, hemoglobin 90 g/L, total bilirubin 1.5 times upper limit normal, ALT and AST within limits (up to 5 times ULN for liver metastasis), and creatinine clearance 60 mL/min
- Use of effective non-drug contraception and no fertility plans for at least 6 months from consent to last dose
- Ability to communicate well with investigators 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 affecting liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immune, musculoskeletal, neurological, psychiatric, skin, or blood systems deemed unsuitable by investigators
- Major surgery within 4 weeks before screening or planned during study
- Pregnant or lactating females
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Use of other anti-tumor drugs or therapies within 4 weeks before dosing
- Significant ECG abnormalities or QTcF interval >470 ms
- Sensory or peripheral neuropathy grade 2 or higher before screening
- Blood donation or major blood loss (>400 mL) within 90 days before screening
- Use of CYP2C8 or CYP3A4 inhibitors or inducers within 28 days before dosing
- Alcohol consumption above 14 units per week within 3 months before screening or inability to abstain during study
- Smoking more than 5 cigarettes per day within 3 months before screening or inability to stop during study
- Clinically significant abnormal vital signs, physical exam, lab results, ECG, or other exams deemed unsuitable by investigators
- History of drug abuse within 6 months before screening or positive drug abuse screening
- Toxicity from prior anti-tumor drugs not recovered to grade 1 or baseline except alopecia
- Use of granulocyte-stimulating growth factor within 2 weeks before dosing
- Participation in any clinical trial within 1 month before screening
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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