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 Cancer Center, Lisboa
Christine Bourguignon (Clinical Operations Assistant) christine.bourguignon (at) eortc.org, EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at) eortc.org, EORTC Headquarters, Brussels
Aleksandra Peric (Senior Clinical Operations Manager) aleksandra.peric (at) eortc.org, EORTC Headquarters, Brussels
Coralie Poncet (Statistician) coralie.poncet (at) eortc.org, 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)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Limoges - Hopital Dupuytren (Limoges, France)
Champalimaud Cancer Center (Lisboa, Portugal)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium)
Institut Curie - l' Hopital de St Cloud (Saint-Cloud, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut du Cancer de Montpellier (Montpellier, France)
Maria Sklodowska-Curie Memorial Cancer Centre (Warsaw, Poland)
Private hospital of Confluent (Nantes, France)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
Western General Hospital (Edinburgh, United Kingdom)
Centers to be activated AZ Groeninge Kortrijk - Campus Kennedylaan (Kortrijk, Belgium)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02032823
NCT number NCT02032823
EudraCT 2013-003839-30