Proposal for Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials: The STEEP System
Memorial Sloan Kettering Cancer Center · Sunnybrook Health Science Centre · +6 more institutions
Abstract
A panel of experts in breast cancer clinical trials representing medical oncology, biostatistics, and correlative science convened to formulate standard definitions and address the confusion that nonstandard definitions of widely used end point terms for a breast cancer clinical trial can generate. We propose standard definitions for efficacy end points and events in early-stage adjuvant breast cancer clinical trials. In some cases, it is expected that the standard end points may not address a specific trial question, so that modified or customized end points would need to be prospectively defined and consistently used.
The use of the proposed common end point definitions will facilitate interpretation of trial outcomes. This approach may be adopted to develop standard outcome definitions for use in trials involving other cancer sites.
Citation impact
- FWCI
- 20.39
- Percentile
- 100%
- References
- 9
Authors
11- CAClifford A. HudisCorresponding
Memorial Sloan Kettering Cancer Center
- WEWilliam E. Barlow
Sunnybrook Health Science Centre, Memorial Sloan Kettering Cancer Center, University of Pittsburgh, Queen's University, Cancer Research And Biostatistics, Emmes (United States), Dana-Farber Cancer Institute, National Cancer Institute
- JPJoseph P. Costantino
Sunnybrook Health Science Centre, Memorial Sloan Kettering Cancer Center, University of Pittsburgh, Queen's University, Cancer Research And Biostatistics, Emmes (United States), Dana-Farber Cancer Institute, National Cancer Institute
- RJRobert J. Gray
Sunnybrook Health Science Centre, Memorial Sloan Kettering Cancer Center, University of Pittsburgh, Queen's University, Cancer Research And Biostatistics, Emmes (United States), Dana-Farber Cancer Institute, National Cancer Institute
- KIKathleen I. Pritchard
Sunnybrook Health Science Centre, Memorial Sloan Kettering Cancer Center, University of Pittsburgh, Queen's University, Cancer Research And Biostatistics, Emmes (United States), Dana-Farber Cancer Institute, National Cancer Institute
Topics & keywords
- Breast cancer
- Medicine
- Clinical trial
- Clinical endpoint
- Cancer
- Medical physics
- End point
- Oncology
- Good health and well-being