Clinical Trial Details
EORTC-1513-BCG
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PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 (HER2)-negative early breast Cancer
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 14-Nov-2016 |
| Data management at EORTC | No |
| Design |
Phase 3 Randomized open label |
| Targeted Sample size | EORTC Groups: 460 - All Groups: 5600 |
| Treatment |
Drug Palbociclib |
| Study Staff |
Fatima Cardoso (Study Coordinator) , Champalimaud Clinical Center, Lisboa Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels Laura De Meulemeester (Senior Clinical Operations Manager) , 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 Breast International Group Austrian Breast and Colorectal Cancer Study Group |
| Recruiting centers |
Azienda Ospedaliera Città della Salute e della Scienza di Torino - Gynecologic Oncology Ospedale S.Anna and University of Turin (Torino, Italy) CHU Saint-Pierre-Site Porte de Hal (Brussels, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) Champalimaud Clinical Center (Lisboa, Portugal) Cliniques Universitaires Saint-Luc (Brussels, Belgium) GasthuisZusters Antwerpen - Sint-Augustinus (Wilrijk, Belgium) Grand Hopital de Charleroi - Site Notre Dame (Charleroi, Belgium) Hopitaux universitaires de Geneve - HUG - site de Cluse-Roseraie (Geneve, Switzerland) Institut Jules Bordet (Anderlecht, Belgium) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Rabin Medical Center - Tel Aviv (Petah Tikva, Israel) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) |
| Protocol summary | http://clinicaltrials.gov/study/NCT02513394 |
| NCT number | NCT02513394 |
| EudraCT | 2014-005181-30 |
| Financial Support | Educational Grant |
