title: A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients.
abstract: Trastuzumab has been widely used among the breast cancer patients with human epidermal growth factor receptor 2 (HER2) overexpression. The genetically engineered trastuzumab traded as Cipterbin® was developed in China since 2003. We have disclosed the phase I clinical trial data of safety, pharmacokinetic profile (PK) in patients with metastasis breast cancer. Subjects identified as HER2 strong positive received single intravenously doses of 100, 250 or 500 mg Cipterbin® in dose-escalation manner. The safety evaluations were recorded and plasma concentration profiles for the drug were analyzed. 27 Chinese metastatic breast cancer patients were enrolled in this study. Patients in each group of different dosage were well-tolerated. The most frequently drug-related adverse events were fever (59.3 %), transaminase increased (22.2 %), chills (18.5 %) and arrhythmia (18.5 %). Only one patient with severe adverse event was observed in 250 mg group revealing brachycardia. PK profile analysis showed that sera steady concentration could be reached in dose-proportional manner, except volume of distribution (Vd) and clearance (CL), which reached peak values at 250 mg administration cohort. This genetically engineered HER2-target antibody had demonstrated the accepted safety with well-tolerated.
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.|Department of Medical Oncology, Beijing Key Lab for Therapeutic Cancer Vaccines, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Beijing, 100038 China.
authors.forename: Xinna
authors.initials: X
authors.lastname: Zhou
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.
authors.forename: Jing
authors.initials: J
authors.lastname: Yu
authors.affiliation: Phase I Clinical Center, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Beijing, 100038 China.
authors.forename: Wenmiao
authors.initials: W
authors.lastname: Wang
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.
authors.forename: Guohong
authors.initials: G
authors.lastname: Song
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.|Department of Medical Oncology, Beijing Key Lab for Therapeutic Cancer Vaccines, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Beijing, 100038 China.
authors.forename: Xiaoli
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.|Department of Medical Oncology, Beijing Key Lab for Therapeutic Cancer Vaccines, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Beijing, 100038 China.
authors.forename: Jun
authors.initials: J
authors.lastname: Ren
authors.affiliation: Department of Medical Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital & Institute, Peking University School of Oncology, 52 Fucheng Rd, Beijing, 100142 China.
authors.forename: Lijun
authors.initials: L
authors.lastname: Di
authors.affiliation: Phase I Clinical Center, Beijing Shijitan Hospital, Capital Medical University, 10 Tieyi Rd, Beijing, 100038 China.
authors.forename: Xinghe
authors.initials: X
authors.lastname: Wang
keywords: Breast cancer; HER2 overexpressed; Pharmacokinetics; Trastuzumab