title: Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.
abstract: OBJECTIVE
  Standardized definitions of breast cancer clinical trial end points must be adopted to permit the consistent interpretation and analysis of breast cancer clinical trials and to facilitate cross-trial comparisons and meta-analyses. Standardizing terms will allow for uniformity in data collection across studies, which will optimize clinical trial utility and efficiency. A given end point term (eg, overall survival) used in a breast cancer trial should always encompass the same set of events (eg, death attributable to breast cancer, death attributable to cause other than breast cancer, death from unknown cause), and, in turn, each event within that end point should be commonly defined across end points and studies.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. hudisc@mskcc.org
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.forename: William E
authors.initials: WE
authors.lastname: Barlow
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Costantino
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gray
authors.forename: Kathleen I
authors.initials: KI
authors.lastname: Pritchard
authors.forename: Judith-Anne W
authors.initials: JA
authors.lastname: Chapman
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Sparano
authors.forename: Sally
authors.initials: S
authors.lastname: Hunsberger
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Enos
authors.forename: Richard D
authors.initials: RD
authors.lastname: Gelber
authors.forename: Jo Anne
authors.initials: JA
authors.lastname: Zujewski
mesh_terms: D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018270:Carcinoma, Ductal, Breast / Q000401:mortality / Q000473:pathology / Q000628:therapy; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000401:mortality / Q000473:pathology / Q000628:therapy; D018275:Carcinoma, Lobular / Q000401:mortality / Q000473:pathology / Q000628:therapy; D017024:Chemotherapy, Adjuvant / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards*; D005260:Female; D006801:Humans; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy; D018714:Radiotherapy, Adjuvant / Q000592:standards*; D015996:Survival Rate