Study

EORTC-10041-BCG

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 Back to result

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, Study Coordinator), Institut Jules Bordet, Anderlecht
  • Katrien Baus (Admin. assistant DM), EORTC Headquarters, Brussels
  • Melanie Beauvois (Clinical Operations Manager), 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)
  • 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)
  • Gesellschaft für onkologische Studien, Praxismanagement und –Logistik (Troisdorf, Germany)
  • Gustave Roussy (VILLEJUIF CEDEX, France)
  • HUB-Hopital Universitaires Erasme (Brussels, Belgium)
  • Haaglanden MC - locatie Antoniushove ( Leidschendam, Netherlands)
  • Hopital Europeen (Marseille, France)
  • Hopitaux du Leman - Site Georges Pianta (Thonon les Bains, France)
  • 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)
  • Leiden University Medical Centre (Leiden, Netherlands)
  • 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)
  • 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)
  • 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 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