Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)†

Ann Oncol. 2015 May;26(5):873-879. doi: 10.1093/annonc/mdv106. Epub 2015 Feb 27.


Background: Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer.

Patients and methods: A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts.

Results: Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings.

Conclusion: The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT.

Keywords: breast cancer; efficacy measure; guidelines; randomized, controlled trial; time-to-event end point.

Publication types

  • Consensus Development Conference
  • Practice Guideline
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Breast Neoplasms / diagnosis
  • Breast Neoplasms / mortality
  • Breast Neoplasms / therapy*
  • Consensus
  • Delphi Technique
  • Disease Progression
  • Disease-Free Survival
  • Endpoint Determination / classification
  • Endpoint Determination / standards*
  • Female
  • Humans
  • Randomized Controlled Trials as Topic / classification
  • Randomized Controlled Trials as Topic / standards*
  • Research Design / standards*
  • Terminology as Topic*
  • Time Factors
  • Treatment Failure