Publications by authors named "Corsee Sanders"
Purpose: To evaluate the concordance between HER2 gene amplification, determined by fluorescence in situ hybridization (FISH), and HER2 protein overexpression assessed by an immunohistochemical (IHC) assay. The IHC protocol used was a research assay, known as the Clinical Trial Assay (CTA), developed to select women with metastatic breast cancer (MBC) for three pivotal clinical trials of trastuzumab therapy.
Methods: A direct-labeled, dual-probe FISH assay was used to determine HER2 amplification in 623 fixed breast cancer tissue specimens.
Article Synopsis
- An industry survey was conducted by a PhRMA/FDA Working Group in 2002 to gather insights on active control trials for a non-inferiority workshop.
- The survey aimed to assess current practices in designing and analyzing active control studies and pinpoint regulatory guidance needs.
- Results were shared at a PhRMA workshop in November 2002, and this paper summarizes those findings.