Clinical Trial Details

EORTC-10041-BCG

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MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid Chemo Therapy): A prospective, randomized study comparing the 70-gene signature with the common clinicpathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes"

Study documentation

Trial Status LT-FU ongoing
Dates Date of activation: 07-Dec-2006
Date Step1 close: 08-Jul-2011
Date Step2 close: 03-Oct-2011
Data management at EORTC Yes
Design Phase 3
Randomized open label
Targeted Sample size EORTC Groups: 4000 - All Groups: 6000
Treatment Drug, Drug
Fluorouracil, Capecitabine, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Letrozole, Methotrexate, Tamoxifen
Study Staff Fatima Cardoso (Study Coordinator) , Champalimaud Clinical Center, Lisboa
Martine Piccart (Study Coordinator) , Institut Jules Bordet-Hopital Universitaire ULB, Brussels
Emiel Rutgers (Study Coordinator) , The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam
Katrien Baus (Admin. assistant DM) , EORTC Headquarters, Brussels
Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Nadine Galonde (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Selin Gundogan (Junior Clinical Operations Manager) , EORTC Headquarters, Brussels
Gracia Katanga (Admin. assistant DM) , EORTC Headquarters, Brussels
Belma Malanda (Project Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Bart Meulemans (Data Manager) , EORTC Headquarters, Brussels
Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Coralie Poncet (Statistician) , EORTC Headquarters, Brussels
Type of cancer Breast
Participating groups EORTC Breast Cancer Group
Breast International Group
Gruppo Oncologico Italiano Ricercia Clinica
Borstkanker Onderzoeksgroup Nederland
National Cancer Research Institute - Breast Cancer Group
West German Study Group
Grupo espanol de estudio, tratamiento y otras estrategias experimentales en tumores solidos
SI_IOL
Recruiting centers AZ Delta (Roeselare, Belgium)
Arcispedale Di S. Maria Nuova (Reggio Emilia, Italy)
Asklepios Paulinen Klinik (Wiesbaden, Germany)
Asklepios Paulinen Klinik (Wiesbaden, Germany)
Asklepios Paulinen Klinik (Wiesbaden, Germany)
Azienda Sanitaria Locale di Viterbo (Viterbo, Italy)
Azienda Sanitaria Locale di Viterbo (Viterbo, Italy)
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital (Legnago, Italy)
Barts Health NHS Trust - St. Bartholomew'S Hospital (London, United Kingdom)
CH de Mulhouse - Hopital Emile Muller-Moenchsberg (Mulhouse, France)
CHU Mont Godinne - UCL Namur (Yvoir, Belgium)
CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium)
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (Toulouse, France)
Centre Antoine Lacassagne (Nice, France)
Centre Eugene Marquis (Rennes, France)
Centre Francois Baclesse (CLCC) (Caen, France)
Centre Georges-Francois-Leclerc (Dijon, France)
Centre Hospitalier Rene Dubos (Pontoise, France)
Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland)
Centre Hospitalier de Blois (Blois, France)
Centre Jean Perrin (Clermont-Ferrand, France)
Centre Leon Berard (Lyon, France)
Centre d'Oncologie de Gentilly (Nancy, France)
Charite - Universitaetsmedizin Berlin - Campus Mitte (Berlin, Germany)
Clinique Hartmann (Neuilly-Sur-Seine, France)
Clinique Sainte-Marie (Osny, France)
Cliniques Universitaires Saint-Luc (Brussels, Belgium)
DRK Kliniken Berlin Koepenick (Berlin, Germany)
Deventer Ziekenhuis (Deventer, Netherlands)
Diakonessenhuis (Utrecht, Netherlands)
Dijklander Ziekenhuis (Purmerend, Netherlands)
Evangelisches Krankenhaus Bethesda (Duisburg 1, Germany)
Fundacion Instituto Valenciano De Oncologia (Valencia, Spain)
Gelre Ziekenhuizen - Lukas Locatie (Apeldoorn, Netherlands)
Gelre Ziekenhuizen - Lukas Locatie (Apeldoorn, Netherlands)
Gesellschaft für onkologische Studien, Praxismanagement und –Logistik (Troisdorf, Germany)
Gustave Roussy (Villejuif, France)
Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
Hopital De Jolimont (Haine St Paul, Belgium)
Hopital Europeen (Marseille, France)
Hopital Universitaires Erasme (Brussels, Belgium)
Hopitaux du Leman - Site Georges Pianta (Thonon les Bains, France)
Hospital Clinico Universitario De Valencia (Valencia, Spain)
Hospital Clinico Universitario De Valencia (Valencia, Spain)
Hospital De La Santa Creu I Sant Pau (Barcelona, Spain)
Hospital San Pedro de Alcantara (Caceres, Spain)
Hospital Son Llatzer (Palma De Mallorca, Spain)
Hospital Universitari Arnau De Vilanova (Lleida, Spain)
Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain)
Hospital Universitario 12 De Octubre (Madrid, Spain)
ICO Girona - Hospital Doctor Josep Trueta (Institut Catala D'Oncologia) (Girona, Spain)
ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain)
IRCCS - AUO San Martino - IST (Genova, Italy)
IRCCS - Istituto Tumori "Giovanni Paolo II" (Bari, Italy)
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy)
Institut Bergonie (Bordeaux, France)
Institut Curie - l' Hopital de St Cloud (Saint-Cloud, France)
Institut Curie- Hopital de Paris (Paris, France)
Institut Godinot (Reims, France)
Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium)
Institut Paoli-Calmettes (Marseille, France)
Institut de Cancerologie de Lorraine (Vandoeuvre-Les-Nancy, France)
Institut de Cancerologie de l’Ouest (ICO) - Angers (Angers, France)
Institut du Cancer Avignon - Provence (Avignon, France)
Instituto Oncologico (San Sebastian, Spain)
Isala Klinieken (Zwolle, Netherlands)
Jeroen Bosch Ziekenhuis ('s-Hertogenbosch, Netherlands)
Klinikum Oldenburg (Oldenburg, Germany)
Klinikum Sindelfingen-Boeblingen (Boeblingen, Germany)
Kreiskrankenhaus Luedenscheid (Luedenscheid, Germany)
Kreiskrankenhaus Luedenscheid (Luedenscheid, Germany)
Leiden University Medical Centre (Leiden, Netherlands)
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt (Muenchen, Germany)
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt (Muenchen, Germany)
Marienhospital Witten (Witten, Germany)
Meander Medisch Centrum - De Lichtenberg (Amersfoort, Netherlands)
Medisch Centrum Leeuwarden-Zuid (Leeuwarden, Netherlands)
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom)
NHS Lanarkshire- Wishaw General Hospital (Wishaw, United Kingdom)
NHS Lothian - Western General Hospital (Edinburgh, United Kingdom)
NHS Tayside - Ninewells Hospital (Dundee, Scotland, United Kingdom)
Niels-Stensen-Kliniken - Franziskus-Hospital Harderberg (Georgsmarienhuette, Germany)
Nij Smellinghe (Drachten, Netherlands)
Noordwest Ziekenhuisgroep - Site Alkmaar (Alkmaar, Netherlands)
Notdienstpraxis am Evangelischen Krankenhaus Bethesda (Moenchengladbach, Germany)
Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands)
Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium)
Ospedale B. Ramazzini (Carpi, Italy)
Ospedale Carlo Poma (Mantova, Italy)
Ospedale Civile Sondrio (Sondrio, Italy)
Ospedale Generale Regionale (Bolzano, Italy)
Ospedale Generale Regionale (Bolzano, Italy)
Ostalb-Klinikum Aalen (Aalen, Germany)
Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom)
Princess Alexandra Hospital (Harlow, United Kingdom)
Rijnland Ziekenhuis-Alrijne Zorggroep (Leiderdorp, Netherlands)
Rijnstate Hospital (Arnhem, Netherlands)
Rijnstate Hospital (Arnhem, Netherlands)
Rimini Hospital Unit - Infermi Hospital (Rimini, Italy)
Robert-Bosch Krankenhaus (Stuttgart, Germany)
Spaarne Gasthuis Haarlem Zuid (Haarlem, Netherlands)
Spaarne Gasthuis Hoofddorp (Hoofddorp, Netherlands)
St Elisabeth-Krankenhaus (Koeln, Germany)
St. Johannes Hospital (Dortmund, Germany)
The Institute Of Oncology (Ljubljana, Slovenia)
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands)
The Royal Bournemouth Hospital (Dorset, United Kingdom)
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany)
Universitaetsklinikum Erlangen-Universitaetsstr (Erlangen, Germany)
Universitaetsklinikum Muenster, Zentralklinikum (Muenster, Germany)
Universitaetsklinikum Tuebingen-Frauenklinik (Tuebingen, Germany)
Universitair Ziekenhuis Antwerpen (Edegem, Belgium)
University Hospital Frankfurt- Goethe University (Frankfurt Am Main, Germany)
University Hospital Frankfurt- Goethe University (Frankfurt Am Main, Germany)
University Hospitals Bristol NHS Foundation Trust - Bristol Royal Infirmary (Bristol, United Kingdom)
University Hospitals Bristol NHS Foundation Trust - Bristol Royal Infirmary (Bristol, United Kingdom)
University Medical Center Maribor (Maribor, Slovenia)
Wilhelm-Anton-Hospital Goch (Goch, Germany)
ZNA Middelheim (Antwerpen, Belgium)
Ziekenhuisgroep Twente - Twenteborg Ziekenhuis (Almelo, Netherlands)
Zuyderland Medisch Centrum, Heerlen (Heerlen, Netherlands)
Protocol summary http://clinicaltrials.gov/ct/show/NCT00433589
NCT number NCT00433589
EudraCT 2005-002625-31
Financial Support Educational Grant