Clinical Trial Details
EORTC-1324-BCG
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A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
Trial Status | Closed to Patient Entry |
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Dates |
Date of activation: 22-Apr-2014 |
Data management at EORTC | No |
Design |
Phase 3 Randomized blind |
Targeted Sample size | EORTC Groups: 45 - All Groups: 1320 |
Treatment |
Drug Olaparib |
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 National Surgical Adjuvant Breast and Bowel Project |
Recruiting centers |
AZ Damiaan (Oostende, Belgium) AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) Champalimaud Clinical Center (Lisboa, Portugal) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Hopital Universitaires Erasme (Brussels, Belgium) Hospital prive du Confluent - Centre Catherine de Sienne (NANTES CEDEX 2, France) Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France) Institut Jules Bordet (Anderlecht, Belgium) Institut du Cancer de Montpellier (MONTPELLIER CEDEX 5, France) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) NHS Lothian - Western General Hospital (Edinburgh, United Kingdom) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) |
Protocol summary | http://clinicaltrials.gov/study/NCT02032823 |
NCT number | NCT02032823 |
EudraCT | 2013-003839-30 |
Financial Support | Fully supported |