Clinical Trial Details
EORTC-90091-10093-NOCI-BCG
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TRastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("Treat CTC" trial)
| 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 Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Diem Chi Nguyen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Tiana Raveloarivahy (Data Manager) , EORTC Headquarters, Brussels |
| Type of cancer | Breast |
| Participating groups |
EORTC Network of Core Institutions 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) Gustave Roussy (VILLEJUIF CEDEX, France) Gynäkologisch-Onkologischen Schwerpunktpraxis (Hannover, Germany) HELIOS Klinik Rottweil (Rottweil, Germany) Hopital De Jolimont (Haine St Paul, Belgium) Hopital Universitaire Brugmann (Brussels, Belgium) 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) 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) UKE - University Cancer Center (Hamburg, Germany) 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 (Greifswald, Germany) Universitaetsklinikum Koeln (Koeln, Germany) Universitaetsklinikum Schleswig-Holstein - Campus Kiel (Kiel, Germany) Universitaetsklinikum Tuebingen-Frauenklinik (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) Medizinisches Zentrum Ulm (Ulm, 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/ct/show/NCT01548677 |
| NCT number | NCT01548677 |
| EudraCT | 2009-017485-23 |
| Financial Support | Educational Grant |
