EORTC-90091-10093-BCG

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TRastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("Treat CTC" trial)

Study documentation

Trial Status	All trial activities ended
Dates	Date of activation: 26-Apr-2013 Date Step1 close: 03-Oct-2016
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 25 - All Groups: 174
Treatment	Drug Trastuzumab
Study Staff	Michail Ignatiadis (Study Coordinator) , Institut Jules Bordet, Anderlecht Melanie Beauvois (Clinical Operations Manager) , EORTC Headquarters, Brussels Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer	Breast
Participating groups	EORTC Breast Cancer Group UNICANCER SUCCESS
Recruiting centers	AZ Damiaan (Oostende, Belgium) C.H.U. Sart-Tilman (Liege, Belgium) CH de Valence (VALENCE CEDEX 9, France) CHU de Grenoble - La Tronche - Hopital A. Michallon (GRENOBLE CEDEX 9, France) CHU de Limoges - Hopital Dupuytren (LIMOGES CEDEX 1, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Hospitalier Alpes Léman (Contamine sur Arve, France) Centre Hospitalier D'Annecy (Metz-Tessy, France) Centre Hospitalier Departemental Vendee (LA ROCHE SUR YON CEDEX 9, France) Centre Hospitalier de Versailles - Hopital Andre Mignot (LE CHESNAY CEDEX, France) Clinique de la Sauvegarde (LYON, France) Diakonie-Klinikum Schwäbisch Hall gGmbH (Schwaebisch Hall, Germany) Frauenärztliche Gemeinschaftspraxis Lorenz / Hecker / Kreiss-Sender / Akkayagil (Braunschweig, Germany) GRN-Klinik Weinheim (Weinheim, Germany) Gemeinschaftspraxis Augsburg (Augsburg, Germany) Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert (Lueneburg, Germany) Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer (Hildesheim, Germany) Gesellschaft für onkologische Studien, Praxismanagement und –Logistik (Troisdorf, Germany) Gynäkologisch-Onkologischen Schwerpunktpraxis (Hannover, Germany) HELIOS Klinik Rottweil (Rottweil, Germany) Hopital Universitaires Erasme (Brussels, Belgium) Hopitaux Universitaires de Strasbourg - Hôpital civil (STRASBOURG CEDEX, France) Hospital prive du Confluent - Centre Catherine de Sienne (NANTES CEDEX 2, France) Institut Bergonie (Bordeaux, France) Institut Curie - l' Hopital de St Cloud (SAINT CLOUD, France) Institut Curie- Hopital de Paris (PARIS CEDEX 05, France) Institut Jules Bordet (Anderlecht, Belgium) Kliniken Landkreis Sigmaringen GmbH (Sigmaringen, Germany) Klinikum Frankfurt Hoechst GmbH (Frankfurt Am Main Hochst, Germany) Klinikum Landshut (Landshut, Germany) Klinikum Ludwigsburg (Ludwigsburg, Germany) Klinikum Schwaebisch-Gmuend (Mutlangen, Germany) Klinikum Sindelfingen-Boeblingen (Boeblingen, Germany) Klinikum St Georg - Standort Eutritzsch (Leipzig, Germany) Klinikum St. Marien (Amberg, Germany) Klinikum Stuttgart (Stuttgart, Germany) Klinikum Traunstein (Traunstein, Germany) Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH (Schweinfurt, Germany) Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt (Muenchen, Germany) Marienhospital Bottrop gGmbH (Bottrop, Germany) Medizinische Hochschule Hannover (Hannover, Germany) Medizinischen Zentrum Bonn (Bonn, Germany) Medizinisches Zentrum fuer Haematologie und Onkologie Munchen (Muenchen, Germany) Muencher Onkol. Praxis Elisenhof (Muenchen, Germany) Onkologische Praxis Oldenburg (Oldenburg , Germany) Onkologische Schwerpunktpraxis Wuppertal (Wuppertal, Germany) Onkologische-Hämatologischen Schwerpunktpraxis (Bremen, Germany) Onkozentrum Dresden/Freiberg (Dresden, Germany) Onze Lieve Vrouw Ziekenhuis (Aalst, Belgium) Oxford University Hospitals NHS Trust - Churchill Hospital (Oxford, United Kingdom) Pole Hospitalier Jolimont - Hopital Jolimont (Haine-Saint-Paul, Belgium) Praxisklinik Krebsheilkunde für Frauen (Berlin, Germany) RoMed Klinikum Rosenheim (Rosenheim, Germany) St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG (Karlsruhe, Germany) Staedtische Kliniken (Esslingen, Germany) Studienzentrum Onkologie Ravensburg (Ravensburg, Germany) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinik Dusseldorf (Duesseldorf, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) Universitaetsklinikum Erlangen-Palmsanlage (Erlangen, Germany) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitaetsklinikum Greifswald der Ernst Morizt Arndt Univ. Greifswald AoR (Greifswald, Germany) Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center (Hamburg, Germany) Universitaetsklinikum Koeln (Koeln, Germany) Universitaetsklinikum Schleswig-Holstein - Campus Kiel (Kiel, Germany) Universitaetsklinikum Tuebingen-calwerstrasse (Tuebingen, Germany) Universitaetsklinikum Ulm-Michelsberg (Ulm, Germany) University General Hospital Heraklion (Heraklion, Greece)
Centers to be activated	Albertinen-Krankenhaus (Hamburg, Germany) Centre Hospitalier de Perpignan (Perpignan, France) Hochwald Krankenhaus Bad Nauheim (Bad Nauheim, Germany) Klinikum Ernst Von Bergmann (Postdam, Germany) Klinikum Hanau (Hanau, Germany) Klinikum Leverkusen gGmbH (Leverkusen, Germany) NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital (Glasgow, United Kingdom) UHB-Queen Elisabeth Medical Centre (Birmingham, United Kingdom) Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH (Aachen, Germany)
Protocol summary	http://clinicaltrials.gov/study/NCT01548677
NCT number	NCT01548677
EudraCT	2009-017485-23
Financial Support	Educational Grant