Fiche publication
Date publication
juin 2009
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PIVOT Xavier
Tous les auteurs :
Pauporte I, Faure C, Pivot X
Résumé
The PHARE trial (NCT-00381901) has been running since May 2006 and continues to consistently recruit patients. It is sponsored by the National Cancer Institute, France. The aim of this trial is to randomly compare a shorter trastuzumab exposure, six vs 12 months, in patients treated in an adjuvant setting. More than 450 clinicians and a hundred clinical research associates are involved. About 180 investigational sites, either public or private cancer treatment centres are participating in the trial. A thousand patients are recruited per year, which means approximately one patient in four treated with adjuvant trastuzumab in France. Each French cancer treatment centre has been invited to participate in this trial. The design of the study is pragmatic; every patient treated with trastuzumab in this setting is eligible. Only data necessary for the endpoints analysis are collected and the trial follow-up is identical to routine practice. The design of the trial and its transparency seem to be the keys of such a success. Scientific collaboration was established with international teams involved in similar trials.
Référence
Oncologie. 2009 Jun;11(6):348-52
