A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer
Abstract Purpose The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast c...
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| Format: | Article |
| Language: | English |
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Springer
2025-01-01
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| Series: | Journal of Cancer Research and Clinical Oncology |
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| Online Access: | https://doi.org/10.1007/s00432-025-06086-0 |
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| author | Jingshu Wang Xiuping Lai Herui Yao Hui Yang Xiaolong Cao Xiaochen Wang Ying Wang Weiqi Nian Xiaodong Zheng Qingxiu Mai Anding Liu Xiaozhi Lv Xiaoying Bi Junyi Chen Junyan Wu Suiwen Ye |
| author_facet | Jingshu Wang Xiuping Lai Herui Yao Hui Yang Xiaolong Cao Xiaochen Wang Ying Wang Weiqi Nian Xiaodong Zheng Qingxiu Mai Anding Liu Xiaozhi Lv Xiaoying Bi Junyi Chen Junyan Wu Suiwen Ye |
| author_sort | Jingshu Wang |
| collection | DOAJ |
| description | Abstract Purpose The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer. Methods To achieve these goals, the trial employed a randomized, open-label, two-formulation crossover dosing strategy among Chinese patients with metastatic breast cancer. Pharmacokinetic (PK) evaluation was conducted through the collection of blood samples, and the liquid chromatography tandem mass spectrometry (LC/MS/MS) method was leveraged to quantify plasma concentrations of both liposome-encapsulated doxorubicin and non-encapsulated doxorubicin in patients. Throughout the trial, all adverse events observed in the patients were meticulously assessed. Results The results indicated that the maximum concentration (Cmax), AUC from time zero to the last measurable concentration (AUC0-t), and AUC extrapolated to infinity (AUC0-∞) of in vivo non-encapsulated doxorubicin after administration of both formulations fell within the 80.00%–125.00% range at a 90% confidence interval. Conclusion These findings strongly indicated that the tested formulations were bioequivalent to the reference formulation. The results also demonstrated that both formulations were well-tolerated, further establishing their safety profile in the context of metastatic breast cancer treatment. Trial registration Chinadrugtrials.org.cn Identifier: CTR20200878. |
| format | Article |
| id | doaj-art-9a2ce9251d194bdf9d28182bd694e868 |
| institution | Kabale University |
| issn | 1432-1335 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Springer |
| record_format | Article |
| series | Journal of Cancer Research and Clinical Oncology |
| spelling | doaj-art-9a2ce9251d194bdf9d28182bd694e8682025-02-09T12:10:36ZengSpringerJournal of Cancer Research and Clinical Oncology1432-13352025-01-01151111210.1007/s00432-025-06086-0A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancerJingshu Wang0Xiuping Lai1Herui Yao2Hui Yang3Xiaolong Cao4Xiaochen Wang5Ying Wang6Weiqi Nian7Xiaodong Zheng8Qingxiu Mai9Anding Liu10Xiaozhi Lv11Xiaoying Bi12Junyi Chen13Junyan Wu14Suiwen Ye15Department of Medical Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityDepartment of Pharmacy, Guangzhou Panyu Central HospitalDepartment of Oncology, Panyu Central HospitalDepartment of Breast Surgery, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical CollegePhase I Clinical Trial Centre, Zhejiang Provincial People’s Hospital, People’s Hospital of Hangzhou Medical CollegeDepartment of Phase I Clinical Trial Center, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer HospitalDepartment of Breast Cancer, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer HospitalPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityShanghai Xihua Scientific Co., Ltd.Phase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityPhase I Clinical Trial Centre, Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityAbstract Purpose The primary objectives of this trial were aimed at exploring the pharmacokinetic profiles and the human bioequivalence of an intravenous liposomal injection of doxorubicin hydrochloride in comparison with a reference formulation in Chinese patients diagnosed with metastatic breast cancer. Methods To achieve these goals, the trial employed a randomized, open-label, two-formulation crossover dosing strategy among Chinese patients with metastatic breast cancer. Pharmacokinetic (PK) evaluation was conducted through the collection of blood samples, and the liquid chromatography tandem mass spectrometry (LC/MS/MS) method was leveraged to quantify plasma concentrations of both liposome-encapsulated doxorubicin and non-encapsulated doxorubicin in patients. Throughout the trial, all adverse events observed in the patients were meticulously assessed. Results The results indicated that the maximum concentration (Cmax), AUC from time zero to the last measurable concentration (AUC0-t), and AUC extrapolated to infinity (AUC0-∞) of in vivo non-encapsulated doxorubicin after administration of both formulations fell within the 80.00%–125.00% range at a 90% confidence interval. Conclusion These findings strongly indicated that the tested formulations were bioequivalent to the reference formulation. The results also demonstrated that both formulations were well-tolerated, further establishing their safety profile in the context of metastatic breast cancer treatment. Trial registration Chinadrugtrials.org.cn Identifier: CTR20200878.https://doi.org/10.1007/s00432-025-06086-0Breast cancerDoxorubicin hydrochloride liposomesPharmacokineticsSafetyBioequivalence test |
| spellingShingle | Jingshu Wang Xiuping Lai Herui Yao Hui Yang Xiaolong Cao Xiaochen Wang Ying Wang Weiqi Nian Xiaodong Zheng Qingxiu Mai Anding Liu Xiaozhi Lv Xiaoying Bi Junyi Chen Junyan Wu Suiwen Ye A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer Journal of Cancer Research and Clinical Oncology Breast cancer Doxorubicin hydrochloride liposomes Pharmacokinetics Safety Bioequivalence test |
| title | A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer |
| title_full | A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer |
| title_fullStr | A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer |
| title_full_unstemmed | A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer |
| title_short | A multicenter, randomized, open label, two formulation, crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in Chinese patients with metastatic breast cancer |
| title_sort | multicenter randomized open label two formulation crossover bioequivalence trial of doxorubicin hydrochloride liposomal injection in chinese patients with metastatic breast cancer |
| topic | Breast cancer Doxorubicin hydrochloride liposomes Pharmacokinetics Safety Bioequivalence test |
| url | https://doi.org/10.1007/s00432-025-06086-0 |
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