Article open access publication

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)

Annals of Oncology, Elsevier, ISSN 1569-8041

Volume 26, 5, 2015

DOI:10.1093/annonc/mdv106, Dimensions: pub.1047239237, PMID: 25725046,



  1. (1) Biostatistic Unit, Montpellier Cancer Institute, Montpellier
  2. (2) Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France
  3. (3) Edinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Edinburgh, UK
  4. (4) Instituut Verbeeten, grid.477181.c
  5. (5) Institute Curie, grid.418596.7
  6. (6) Department of Radiation Oncology, Montpellier Cancer Institute, Montpellier, France
  7. (7) Champalimaud Foundation, grid.421010.6
  8. (8) Institute of Cancer Research, grid.18886.3f
  9. (9) European Organisation for Research and Treatment of Cancer, grid.418936.1
  10. (10) Institut Bergonié, grid.476460.7
  11. (11) Hôpital René Huguenin, grid.418205.a
  12. (12) Hôpital Saint-Antoine, grid.412370.3
  13. (13) Weston Park Cancer Centre, grid.417079.c
  14. (14) University Clinic of Pulmonary and Allergic Diseases Golnik, grid.412388.4
  15. (15) Institut Jules Bordet, grid.418119.4
  16. (16) Institut Claudius Regaud, grid.417829.1
  17. (17) Institut Gustave Roussy, grid.14925.3b
  18. (18) Sorbonne University, grid.462844.8
  19. (19) Department of Surgery
  20. (20) Department of Medical Oncology, Montpellier Cancer Institute, Montpellier, France
  21. (21) Catholic University of Louvain, grid.7942.8
  22. (22) University of Paris-Sud, grid.5842.b
  23. (23) Companhia União Fabril, grid.421304.0
  24. (24) Aarhus University Hospital, grid.154185.c, Central Denmark Region
  25. (25) Centre Jean Perrin, grid.418113.e
  26. (26) Clermont Université, grid.411717.5
  27. (27) European Institute of Oncology, grid.15667.33
  28. (28) University of Milan, grid.4708.b
  29. (29) Antoni van Leeuwenhoek Hospital, grid.430814.a
  30. (30) University of Porto, grid.5808.5
  31. (31) Centre Oscar Lambret, grid.452351.4
  32. (32) Canton of St. Gallen-Hospital, grid.413349.8
  33. (33) Helios Hospital Berlin-Buch, grid.491869.b
  34. (34) Academic Medical Center, grid.5650.6
  35. (35) KU Leuven, grid.5596.f
  36. (36) Universitair Ziekenhuis Leuven, grid.410569.f
  37. (37) Royal Marsden Hospital, grid.424926.f
  38. (38) Centre Hospitalier Universitaire de Besançon, grid.411158.8
  39. (39) Clinical Epidemiology Unit, INSERM CIC 14.01 (Clinical Epidemiology), Bordeaux
  40. (40) Biostatistics and Quality of Life Unit (EA4184), Centre Georges François Leclerc Comprehensive Cancer Centre, Dijon, France


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.


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