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

Study documentation

Trial Status Closed to Patient Entry
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