Bioequivalence of two doxorubicin liposome formulations (LY01612 and Caelyx) using free and encapsulated doxorubicin concentrations in Chinese patients with advanced breast cancer.
Groundbreaking study finds two doxorubicin liposome formulations are bioequivalent, offering new hope for advanced breast cancer patients in China. The research paves the way for more accessible and effective treatment options.
This multicenter, randomized, open-label study compared the pharmacokinetic properties and bioequivalence of a reference doxorubicin formulation (Caelyx) and a newly developed formulation (LY01612) in 48 Chinese patients with advanced breast cancer. The results showed that the two formulations were bioequivalent in terms of free, encapsulated, and total doxorubicin concentrations. Both formulations were well-tolerated, with no significant differences in adverse events. This study provides valuable insights into the development of alternative doxorubicin formulations, potentially expanding treatment options for patients with advanced breast cancer in China.