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"
| 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, Anderlecht 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 Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , 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 Coralie Poncet (Statistician) , EORTC Headquarters, Brussels Yulia Roshchupkina (Clinical Operations Assistant) , EORTC Headquarters, Brussels Bette Stofs (Pharmacovigilance Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Breast |
| Participating groups |
EORTC Breast Cancer Group Breast International Group Gruppo Oncologico Italiano Ricercia Clinica Borstkanker Onderzoek Group Nederland National Cancer Research Institute - Breast Cancer Group Westdeutsche Studiengruppe GmbH Grupo espanol de estudio, tratamiento y otras estrategias experimentales en tumores solidos SI_IOL |
| Recruiting centers |
AUSL Della Romagna - Infermi Hospital -Rimini (Rimini, Italy) AUSL Modena - Ospedale B. Ramazzini (Carpi, Italy) AZ Delta - Campus Rumbeke (Roeselare, Belgium) Asklepios Paulinen Klinik (Wiesbaden, Germany) Asklepios Paulinen Klinik (Wiesbaden, Germany) Asklepios Paulinen Klinik (Wiesbaden, Germany) Azienda Sanitaria Locale di Viterbo - Belcolle Hospital (Viterbo, Italy) Azienda Sanitaria Locale di Viterbo - Belcolle Hospital (Viterbo, Italy) Azienda USL IRCCS Di Reggio Emilia - Maria Nuova (Reggio Emilia, 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 CEDEX 1, France) CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) CHU Mont Godinne - UCL Namur (Yvoir, Belgium) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole (TOULOUSE CEDEX 9, France) CLCC - Jean Perrin (CLERMONT FERRAND , France) Centre Antoine Lacassagne (NICE CEDEX 2, France) Centre Eugene Marquis (RENNES CEDEX, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Hospitalier Rene Dubos (Pontoise, France) Centre Hospitalier Universitaire Vaudois - Lausanne (Lausanne, Switzerland) Centre Hospitalier de Blois (BLOIS CEDEX, France) Centre Leon Berard (Lyon, 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) Evangelischen Krankenhaus Bethesda (Moenchengladbach, Germany) 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 CEDEX, France) Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands) 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 - Istituto Tumori "Giovanni Paolo II" (Bari, Italy) IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" (Meldola, Italy) IRCCS Ospedale San Martino (Genova, Italy) Institut Bergonie (Bordeaux, France) Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut Godinot (REIMS CEDEX, France) Institut Jules Bordet (Anderlecht, Belgium) Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France) Institut Sainte Catherine (AVIGNON CEDEX 9, France) Institut de Cancerologie de Lorraine (VANDOEUVRE LES NANCY CEDEX, France) Institut de Cancerologie de l’Ouest (ICO) - Angers (ANGERS CEDEX 02, France) Instituto Oncologico (San Sebastian, Spain) Isala Klinieken Stichting (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) Onze Lieve Vrouw Gasthuis (Amsterdam, Netherlands) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) 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) Polyclinique De Gentilly - Centre d'Oncologie (Nancy, France) Princess Alexandra Hospital (Harlow, United Kingdom) Rijnland Ziekenhuis-Alrijne Zorggroep (Leiderdorp, Netherlands) Rijnstate Hospital (Arnhem, Netherlands) Rijnstate Hospital (Arnhem, Netherlands) 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) Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany) Universitaetsklinikum Erlangen-Strahlenklinik (Erlangen, Germany) Universitaetsklinikum Muenster, Zentralklinikum (Muenster, Germany) Universitaetsklinikum Tuebingen-calwerstrasse (Tuebingen, Germany) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University Hospital Dorset : The Royal Bournemouth Hospital (Dorset, United Kingdom) 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/study/NCT00433589 |
| NCT number | NCT00433589 |
| EudraCT | 2005-002625-31 |
| Financial Support | Educational Grant |
