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)
Study documentation Publications
| Trial Status | Closed to Patient Entry |
|---|---|
| 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-Hopital Universitaire ULB, Brussels Melanie Beauvois (Clinical Operations Manager) melanie.beauvois (at) eortc.org, EORTC Headquarters, Brussels Christine Bourguignon (Clinical Trial Assistant) christine.bourguignon (at) eortc.org, EORTC Headquarters, Brussels Hanane Lanaya (Pharmacovigilance Manager) hanane.lanaya (at) eortc.org, EORTC Headquarters, Brussels Saskia Litiere (Statistician) saskia.litiere (at) eortc.org, EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at) eortc.org, EORTC Headquarters, Brussels Tiana Raveloarivahy (Data Manager) tiana.raveloarivahy (at) eortc.org, 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, France) CHU Site Sainte-Elisabeth-UCL Namur (Namur, Belgium) CHU de Brest (Brest, France) CHU de Grenoble - La Tronche - Hôpital A. Michallon (Grenoble, France) CHU de Limoges - Hopital Dupuytren (Limoges, France) Centre Hospitalier Alpes Léman (Contamine sur Arve, France) Centre Hospitalier D'Annecy (Metz-Tessy, France) Centre Hospitalier Departemental Vendée (La Roche Sur Yon, France) Centre Hospitalier de Mont-de-Marsan (Mont-de-Marsan, France) Centre Hospitalier de Versailles - Hopital Andre Mignot (Le Chesnay, France) Centre Hospitalier de la Dracénie (Draguignan, France) Centre Regional Francois Baclesse (Caen, France) Clinique de la Sauvegarde (Lyon , France) Diakonie-Klinikum Schwäbisch Hall gGmbH (Schwaebisch Hall, Germany) Ev.-Luth. Diakonissenanstalt Flensburg (Flensburg, 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, France) Gynäkologisch-Onkologischen Schwerpunktpraxis (Hannover, Germany) HELIOS Klinik Rottweil (Rottweil, Germany) HOPE (Muenchen, Germany) Hopital De Jolimont (Haine St Paul, Belgium) Hopital Universitaire Brugmann (Brussels, Belgium) Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme (Brussels, Belgium) Hôpitaux Universitaires de Strasbourg - Hôpital civil (Strasbourg, France) Institut Bergonie (Bordeaux, France) Institut Curie - l' Hopital de St Cloud (Saint-Cloud, France) Institut Curie- Hopital de Paris (Paris, France) Institut Jules Bordet-Hopital Universitaire ULB (Brussels, Belgium) Institut de Cancérologie de Lorraine (Vandoeuvre-Les-Nancy, France) Kliniken Landkreis Sigmaringen GmbH (Sigmaringen, Germany) Klinikum Augsburg (Augsburg, Germany) Klinikum Landshut (Landshut, Germany) Klinikum Ludwigsburg (Ludwigsburg, Germany) Klinikum Schwaebisch-Gmuend (Mutlangen, Germany) Klinikum Sindelfingen-Boeblingen (Boeblingen, 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) Luisenkrankenhaus GmbH & Co. KG (Duesseldorf, Germany) Marienhospital Bottrop gGmbH (Bottrop, Germany) Medizinische Hochschule Hannover (Hannover, Germany) Medizinischen Zentrum Bonn (Bonn, 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) Private hospital of Confluent (Nantes, France) RoMed Klinikum Rosenheim (Rosenheim, Germany) St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG (Karlsruhe, Germany) Staedtische Kliniken (Esslingen, Germany) Staedtische Kliniken Frankfurt Am Main-Hoechst (Frankfurt Am Main Hochst, Germany) Staedtisches Klinikum Leipzig - Klinikum St. Georg GmbH (Leipzig, Germany) Studienzentrum Onkologie Ravensburg (Ravensburg, Germany) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) Universitaets-Krankenhaus Eppendorf (Hamburg, Germany) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinik Dusseldorf (Duesseldorf, Germany) Universitaetsklinik Erlangen (Erlangen, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Carl Gustav Carus (Dresden, Germany) Universitaetsklinikum Freiburg (Freiburg, Germany) Universitaetsklinikum Greifswald - Koerperschaft des oeffentlichen Rechts (Greifswald, Germany) Universitaetsklinikum Koeln (Koeln, Germany) Universitaetsklinikum Schleswig-Holstein - Campus Kiel-Klinik Gynaekologie und Geburtshilfe (Frauenheilkunde) (Kiel, Germany) Universitaetsklinikum Tuebingen-Frauenklinik (Tuebingen, Germany) Universitaetsklinikum Ulm-Michelsberg (Ulm, Germany) University General Hospital Heraklion (Heraklion, Greece) Wiener Krankenanstaltenverbund- Kaiser Franz Josef Hospital (Vienna, Austria) |
| 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) Universitätsklinikum Aachen AÖR - Medizinische Fakultät der RWTH (Aachen, Germany) |
| Protocol summary | http://clinicaltrials.gov/ct/show/NCT01548677 |
| NCT number | NCT01548677 |
| EudraCT | 2009-017485-23 |