EORTC-1502-BCG

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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	All trial activities ended
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 ETOP IBCSG Partners Foundation
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	NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT02536742
NCT number	NCT02536742
EudraCT	2014-005387-15
Financial Support	Educational Grant