Multicenter phase II trial of trastuzumab deruxtecan for HER2-positive unresectable or recurrent biliary tract cancer: HERB trial.
Akihiro OhbaChigusa MorizaneMakoto UenoSatoshi KobayashiYasuyuki KawamotoYoshito KomatsuMasafumi IkedaMitsuhito SasakiNaohiro OkanoJunji FuruseNobuyoshi HiraokaHiroshi YoshidaAya KuchibaRyo SadachiKenichi NakamuraNaoko MatsuiYoshiaki NakamuraWataru OkamotoTakayuki YoshinoTakuji OkusakaPublished in: Future oncology (London, England) (2022)
Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of a humanized monoclonal anti-HER2 antibody, a cleavable tetrapeptide-based linker and a potent topoisomerase I inhibitor. The drug's efficacy has been proven in HER2-positive breast and gastric cancers. The rate of HER2 positivity in biliary tract cancer (BTC) has been reported to be 5-20%, and case reports and clinical trials have suggested that HER2 inhibitors might be active in HER2-positive BTC. Here we describe the rationale and design of the phase II HERB trial that will evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing unresectable or recurrent BTC. The primary end point will be the centrally assessed objective response rate in HER2-positive patients.
Keyphrases
- phase ii
- clinical trial
- open label
- phase iii
- papillary thyroid
- epidermal growth factor receptor
- end stage renal disease
- study protocol
- squamous cell
- newly diagnosed
- ejection fraction
- chronic kidney disease
- metastatic breast cancer
- placebo controlled
- peritoneal dialysis
- childhood cancer
- lymph node metastasis
- cancer therapy
- tyrosine kinase
- liver metastases
- prognostic factors
- young adults
- case report
- radiation therapy
- patient reported
- drug delivery
- monoclonal antibody