Spots Global Cancer Trial Database for Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
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Trial Identification
Brief Title: Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
Official Title: TRastuzumab in HER2-negative Early Breast Cancer as Adjuvant Treatment for Circulating Tumor Cells (CTC) ("TREAT CTC" Trial)
Study ID: NCT01548677
Interventions
Study Description
Brief Summary: This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood. Eligible patients will be randomised in 1:1 ratio to either the trastuzumab arm or the observation arm.
Detailed Description: This is a randomized phase II trial for patients with HER2 negative primary BC who after completing (neo) adjuvant chemotherapy and surgery have detectable CTC(s) in peripheral blood (see eligibility criteria for details). Eligible patients will be randomized in 1:1 ratio to either the trastuzumab arm or the observation arm. Patients randomized to the trastuzumab arm will receive a total of 6 intravenous (IV) administrations every 3 weeks (loading dose 8 mg/kg IV and 5 cycles at 6 mg/kg every 3 weeks). Patients randomized to observation arm shall be observed for 18 weeks. Left ventricular ejection fraction (LVEF) assessment (MUGA and/or ECHO) will be done at baseline for all patients to be randomized. The next LVEF assessments of weeks 9 and week 18 will be done only in patients randomized to trastuzumab arm. Patient registered but with CTC negative result will not be followed-up.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Onze Lieve Vrouw Ziekenhuis, Aalst, , Belgium
Hopital Universitaire Brugmann, Brussels, , Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels, , Belgium
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet, Brussels, , Belgium
Hopital De Jolimont, Haine St Paul, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
C.H.U. Sart-Tilman, Liege, , Belgium
Clinique et Maternité Sainte Elisabeth, Namur, , Belgium
AZ Damiaan, Oostende, , Belgium
Institut Bergonie, Bordeaux, , France
CHU de Brest, Brest, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier Alpes Léman, Contamine sur Arve, , France
Centre Hospitalier de la Dracénie, Draguignan, , France
CHU de Grenoble - La Tronche - Hôpital A. Michallon, Grenoble, , France
Centre Hospitalier Departemental Vendée, La Roche Sur Yon, , France
Centre Hospitalier de Versailles - Hopital Andre Mignot, Le Chesnay, , France
CHU de Limoges - Hopital Dupuytren, Limoges, , France
Clinique de la Sauvegarde, Lyon, , France
Centre Hospitalier D'Annecy, Metz-Tessy, , France
Centre Hospitalier de Mont-de-Marsan, Mont-de-Marsan, , France
Centre Catherine De Sienne, Nantes, , France
Institut Curie, Paris, , France
Institut Curie - Hopital Rene Huguenin, Saint-Cloud, , France
Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil, Strasbourg, , France
Hopitaux du Leman - Site Georges Pianta, Thonon les Bains, , France
CH de Valence, Valence, , France
Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, , France
Gustave Roussy, Villejuif, , France
Klinikum St. Marien, Amberg, , Germany
Gemeinschaftspraxis Augsburg, Augsburg, , Germany
Klinikum Augsburg, Augsburg, , Germany
Praxisklinik Krebsheilkunde für Frauen, Berlin, , Germany
Klinikum Sindelfingen-Boeblingen, Boeblingen, , Germany
Medizinischen Zentrum Bonn, Bonn, , Germany
Marienhospital Bottrop gGmbH, Bottrop, , Germany
Gemeinschaftspraxis Lorenz / Hecker / Wesche, Braunschweig, , Germany
Onkologische-Hämatologischen Schwerpunktpraxis, Bremen, , Germany
Onkologische Gemeinschaftspraxis, Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
Luisenkrankenhaus GmbH & Co. KG, Duesseldorf, , Germany
Universitaetsklinik Duesseldorf, Duesseldorf, , Germany
Universitaetsklinik Erlangen, Erlangen, , Germany
Universitaetsklinikum - Essen, Essen, , Germany
Staedtische Kliniken, Esslingen, , Germany
Ev.-Luth. Diakonissenanstalt Flensburg, Flensburg, , Germany
Staedtische Kliniken Frankfurt Am Main-Hoechst, Frankfurt Am Main, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Universitaets-Krankenhaus Eppendorf, Hamburg, , Germany
Gynäkologisch-Onkologischen Schwerpunktpraxis, Hannover, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer, Hildesheim, , Germany
St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG, Karlsruhe, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel, Kiel, , Germany
Universitaetsklinikum Koeln, Koeln, , Germany
Klinikum Landshut, Landshut, , Germany
Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH, Leipzig, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert, Lueneburg, , Germany
UniversitaetsMedizin Mannheim, Mannheim, , Germany
Gemeinschaftspraxis Prof. Salat / Dr. Stötzer, Muenchen, , Germany
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt, Muenchen, , Germany
Muencher Onkol. Praxis Elisenhof, Muenchen, , Germany
Klinikum Schwaebisch-Gmuend, Mutlangen, , Germany
Onkologische Praxis Oldenburg, Oldenburg, , Germany
Studienzentrum Onkologie Ravensburg, Ravensburg, , Germany
RoMed Klinikum Rosenheim, Rosenheim, , Germany
HELIOS Kliniken - HELIOS Klinik Rottweil, Rottweil, , Germany
HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz, Schkeuditz, , Germany
Diakonie-Klinikum Schwäbisch Hall gGmbH, Schwaebisch Hall, , Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH, Schweinfurt, , Germany
Kliniken Landkreis Sigmaringen GmbH, Sigmaringen, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Klinikum Traunstein, Traunstein, , Germany
Gesellschaft für onkologische Studien, Praxismanagement und -Logistik, Troisdorf, , Germany
Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen, Tuebingen, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim, Weinheim, , Germany
Onkologische Schwerpunktpraxis Wupperta, Wuppertal, , Germany
Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom
Contact Details
Name: Michail Ignatiadis, MD
Affiliation: Institut Jules Bordet, Brussels, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: Martine Piccart, MD
Affiliation: Institut Jules Bordet, Brussels, Belgium
Role: STUDY_CHAIR
Name: Christos Sotiriou, MD
Affiliation: Institut Jules Bordet, Brussels, Belgium
Role: STUDY_CHAIR
Name: Jean-Yves Pierga, MD
Affiliation: Institut Curie, Paris, France
Role: STUDY_CHAIR
Name: Brigitte Rack, MD
Affiliation: Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt, Munich, Germany
Role: STUDY_CHAIR
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