A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab.
Francisco J EstevaJustin StebbingRebecca N Wood-HorrallPeter J WinkleSung Young LeeSang Joon LeePublished in: Cancer chemotherapy and pharmacology (2018)
These data add to the totality of evidence required to demonstrate biosimilarity. A phase III study of CT-P6-in which equivalent neoadjuvant efficacy to reference trastuzumab has been demonstrated-is ongoing.
Keyphrases
- phase iii
- open label
- image quality
- dual energy
- computed tomography
- epidermal growth factor receptor
- contrast enhanced
- clinical trial
- metastatic breast cancer
- rectal cancer
- positron emission tomography
- lymph node
- electronic health record
- phase ii
- double blind
- magnetic resonance imaging
- study protocol
- placebo controlled
- big data
- randomized controlled trial
- machine learning
- magnetic resonance
- tyrosine kinase