Multicenter Bioequivalence Trial of Doxorubicin in Chinese Metastatic Breast Cancer Patients
Purpose
The main goal of this trial was to study how a new liposomal injection of doxorubicin hydrochloride works in Chinese patients with metastatic breast cancer, comparing it to a standard formulation.
Methods
This study used a randomized, open-label design where patients received both formulations at different times. Blood samples were collected to analyze the drug levels using advanced techniques. All side effects were carefully monitored during the trial.
Results
The findings showed that the key drug levels in the blood for both formulations were similar, falling between 80.00% and 125.00% at a 90% confidence level. This indicates the new formulation is equivalent to the standard one.
Conclusion
The trial confirmed that both formulations of doxorubicin are safe and well-tolerated for treating metastatic breast cancer.
Trial Registration
Chinadrugtrials.org.cn Identifier: CTR20200878
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