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Clinical and biological characterization of Male Breast Cancer : an international retrospective EORTC, BIG and NABCG intergroup study (for the prospective part, please refer to 10085p)

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 27-Dec-2010
Date Step1 close: 03-Sep-2013
Data management at EORTC Yes
Design Cohort
Randomized open label
Targeted Sample size EORTC Groups: 1800 - All Groups: 1800
Study Staff Fatima Cardoso (Study Coordinator) , Champalimaud Clinical Center, Lisboa
Sharon Hermes Giordano (Study Coordinator) , The University of Texas MD Anderson Cancer Center, Houston
Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Nadine Galonde (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Alessandro Gugino (Project Manager) , EORTC Headquarters, Brussels
Selin Gundogan (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Catherine Hermans (Data Manager) , EORTC Headquarters, Brussels
Eleni Mandila (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
Swedish Association of Breast Oncologists
Breast International Group
Schweizerisches Arbeitsgemeinschaft Klin. Krebsforschung
Borstkanker Onderzoeksgroup Nederland
Cancer Trials Ireland / ICORG
Recruiting centers AZ Damiaan (Oostende, Belgium)
AZ Groeninge – Oncology Centre (Kortrijk, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
Cork University Hospital (Cork, Ireland)
Dana-Farber Cancer Institute & Harvard Medical School (Boston, United States of America)
Eastbourne District General Hospital (Eastbourne, United Kingdom)
Fred Hutchison Seattle Cancer Care Alliance (Seattle, United States of America)
Gloucestershire Hospital NHS Foundation Trust - Cheltenham General Hospital (Cheltenham, United Kingdom)
Hopital De Jolimont (Haine St Paul, Belgium)
Hopital Universitaire Brugmann (Brussels, Belgium)
Hopital du Valais - Hopital de Sion (Sion, Switzerland)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Inselspital (Bern, Switzerland)
Institut Jules Bordet (Brussels, Belgium)
Kantonsspital Baden (Baden, Switzerland)
Kantonsspital Baselland - Bruderholz (Bruderholz, Switzerland)
Kantonsspital Baselland - Liestal (Liestal, Switzerland)
Kantonsspital St Gallen (St Gallen, Switzerland)
Kantonsspital Winterthur (Winterthur, Switzerland)
Luzerner Kantonsspital (Luzern, Switzerland)
Mater Misericordia Hospital (Dublin, Ireland)
Medical University Of Gdansk (Gdansk, Poland)
Memorial Sloan-Kettering Cancer Center - Memorial hospital (New York, United States of America)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
Oncology Institute of Southern Switzerland - Ospedale Beata Vergine (Mendrisio, Switzerland)
Royal Sussex County Hospital (Brighton, United Kingdom)
Sonnenhofklinik Engeriedspital (Bern, Switzerland)
Spitalzentrum Biel (Biel, Switzerland)
St. Claraspital (Basel, Switzerland)
St. James'S Hospital (Dublin, Ireland)
St. Vincent'S University Hospital (Dublin, Ireland)
The University of Texas MD Anderson Cancer Center (Houston, United States of America)
Tumor and Breast Center ZeTuP St. Gallen (St Gallen, Switzerland)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UniversitaetsSpital Zurich (Zurich, Switzerland)
Universitaetsspital Basel (Basel, Switzerland)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital of North Tees (Stockton on Tees, United Kingdom)
Waterford Regional Hospital (Waterford, Ireland)
Worthing Hospital (Worthing - West Sussex, United Kingdom)
ZNA Jan Palfijn (Merksem, Belgium)
ZNA Middelheim (Antwerpen, Belgium)
Centers to be activated Mid Cheshire Hospitals NHS Foundation Trust - Leighton Hospital (Crewe, United Kingdom)
Radio-Onkologie Berner Oberland AG (Thun, Switzerland)
Protocol summary
NCT number NCT01101425
Financial Support External Grant