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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) , EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , 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)
Protocol summary
NCT number NCT02536742
EudraCT 2014-005387-15
Financial Support Educational Grant