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A phase II study of Palbociclib plus Fulvestrant for pretreated patients with ER+/HER2- metastatic Breast Cancer; Palbociclib in molecularly characterized ER-Positive/HER2 negative metastatic Breast Study: the PYTHIA study

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 04-May-2016
Date Step1 close: 03-Jun-2019
Data management at EORTC No
Design Phase 2
Randomized blind
Targeted Sample size EORTC Groups: 38 - All Groups: 120
Treatment Drug
Fulvestrant, Palbociclib
Study Staff Francois Duhoux (Study Coordinator) , Cliniques Universitaires Saint-Luc, Brussels
Melanie Beauvois (Clinical Operations Manager) melanie.beauvois (at), EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) christine.bourguignon (at), EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at), EORTC Headquarters, Brussels
Coralie Poncet (Statistician) coralie.poncet (at), EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
International Breast Cancer Study Group
Recruiting centers CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Centers to be activated Western General Hospital (Edinburgh, United Kingdom)
Protocol summary
NCT number NCT02536742
EudraCT 2014-005387-15