ArticleSpringerPlus2015
A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients.
Article in SpringerPlus, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- A randomized, double-blind, parallel-group, single-dose comparative pharmacokinetic study of DRL_TZ, a candidate biosimilar of trastuzumab, with HerceptinThe Indian journal of medical research · 2021Trial
- Real-world outcomes and safety of inetetamab plus pyrotinib and chemotherapy in HER2-positive metastatic breast cancer: A multicenter retrospective study.Therapeutic advances in medical oncology · 2026Article
- Recent Advances in the Development and Clinical Use of HER2 Inhibitors in Non-Small Cell Lung Cancer.Biomolecules · 2025Review
- Inetetamab-Based Regimens for Patients with HER2-Positive Metastatic Breast Cancer: A Real-World Retrospective Study.Breast cancer (Dove Medical Press) · 2025Article
- Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer in first-line/second-line setting.Frontiers in oncology · 2025Article
- Anthracyclines induce cardiotoxicity through a shared gene expression response signature.PLoS genetics · 2024Article
- The Efficacy and Safety of Inetetamab and Pyrotinib in Combination with Vinorelbine for Second-line Therapy and Beyond in HER2-positive Metastatic Breast Cancer: A Single-institution Clinical Experience.Current cancer drug targets · 2024Article
- Exploring the clinical outcomes and safety profile of inetetamab treatment in metastatic breast cancer patients: A multicenter assessment of a Chinese-origin recombinant Anti-HER2 monoclonal antibody.Breast (Edinburgh, Scotland) · 2023Article
- The association of trastuzumab with atrial fibrillation and heart failure in breast cancer patients in routine clinical practice: a population-based propensity score matching and competing risk model analysis.Breast cancer research and treatment · 2023Article
- Inetetamab, a novel anti-HER2 monoclonal antibody, exhibits potent synergistic anticancer effects with cisplatin by inducing pyroptosis in lung adenocarcinoma.International journal of biological sciences · 2023Article
- Systemic investigation of inetetamab in combination with small molecules to treat HER2-overexpressing breast and gastric cancers.Open life sciences · 2023Article
- Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review.Breast (Edinburgh, Scotland) · 2021Article
- LINC01857 as an oncogene regulates CREB1 activation by interacting with CREBBP in breast cancer.Journal of cellular physiology · 2019Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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