Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
- Conditions
- Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastCirculating Tumor Cells
- Interventions
- Registration Number
- NCT01548677
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1317
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herceptin (trastuzumab) trastuzumab 18 weeks
- Primary Outcome Measures
Name Time Method CTC detection 18 weeks post randomisation To compare circulating tumour cell (CTC)detection rate at week 18 between trastuzumab treatment arm and observational arm.
- Secondary Outcome Measures
Name Time Method RFI (recurrence free interval) 2 years after LPI (last patient in) Recurrence Free Interval (RFI) (key secondary endpoint) between trastuzumab and observation
IDFS (Invasive Disease Free Survival) 2 years after LPI Invasive Disease Free Survival between trastuzumab and observation
DFS (disease free survival) 2 years after LPI Disease Free survival between trastuzumab and observation
OS (overall survival) 2 years after LPI Overall Survival between trastuzumab and observation
CTC essay 2 years after LPI To evaluate in a clinical trial setting the feasibility, reliability, within patient reproducibility and variability of the assay for CTC(s)
CTC correlation 2 years after LPI To correlate CTC detection rate at baseline and/or week 18 with RFI, IDFS, DFS, OS
safety (cardiac) 2 years after LPI To assess safety, especially cardiac safety, of trastuzumab in women with HER2 negative primary tumors and CTC
Trial Locations
- Locations (80)
Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet
🇧🇪Brussels, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
C.H.U. Sart-Tilman
🇧🇪Liege, Belgium
CHU de Brest
🇫🇷Brest, France
CHU de Grenoble - La Tronche - Hôpital A. Michallon
🇫🇷Grenoble, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
🇫🇷Le Chesnay, France
Universitaetsklinik Erlangen
🇩🇪Erlangen, Germany
Clinique de la Sauvegarde
🇫🇷Lyon, France
Centre Hospitalier de la Dracénie
🇫🇷Draguignan, France
Centre Catherine De Sienne
🇫🇷Nantes, France
Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil
🇫🇷Strasbourg, France
CH de Valence
🇫🇷Valence, France
Gustave Roussy
🇫🇷Villejuif, France
Clinique et Maternité Sainte Elisabeth
🇧🇪Namur, Belgium
Centre Hospitalier Alpes Léman
🇫🇷Contamine sur Arve, France
CHU de Limoges - Hopital Dupuytren
🇫🇷Limoges, France
Centre Hospitalier D'Annecy
🇫🇷Metz-Tessy, France
Gynäkologisch-Onkologischen Schwerpunktpraxis
🇩🇪Hannover, Germany
Onkologische Praxis Oldenburg
🇩🇪Oldenburg, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Germany
Praxisklinik Krebsheilkunde für Frauen
🇩🇪Berlin, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Dresden, Germany
Universitaetsklinikum - Essen
🇩🇪Essen, Germany
St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG
🇩🇪Karlsruhe, Germany
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Staedtische Kliniken Frankfurt Am Main-Hoechst
🇩🇪Frankfurt Am Main, Germany
UniversitaetsMedizin Mannheim
🇩🇪Mannheim, Germany
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Luisenkrankenhaus GmbH & Co. KG
🇩🇪Duesseldorf, Germany
Hopitaux du Leman - Site Georges Pianta
🇫🇷Thonon les Bains, France
Onkologische-Hämatologischen Schwerpunktpraxis
🇩🇪Bremen, Germany
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Klinikum Landshut
🇩🇪Landshut, Germany
Gemeinschaftspraxis Augsburg
🇩🇪Augsburg, Germany
Gemeinschaftspraxis Prof. Salat / Dr. Stötzer
🇩🇪Muenchen, Germany
Muencher Onkol. Praxis Elisenhof
🇩🇪Muenchen, Germany
Universitaetsklinik Duesseldorf
🇩🇪Duesseldorf, Germany
Diakonie-Klinikum Schwäbisch Hall gGmbH
🇩🇪Schwaebisch Hall, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt gGmbH
🇩🇪Schweinfurt, Germany
Klinikum St. Marien
🇩🇪Amberg, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
🇩🇪Kiel, Germany
Klinikum Schwaebisch-Gmuend
🇩🇪Mutlangen, Germany
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
🇩🇪Hildesheim, Germany
Klinikum Stuttgart
🇩🇪Stuttgart, Germany
Gesellschaft für onkologische Studien, Praxismanagement und -Logistik
🇩🇪Troisdorf, Germany
Staedtisches Klinikum Leipzig - Klinikum St. Georg gGmbH
🇩🇪Leipzig, Germany
Universitaetsklinikum Koeln
🇩🇪Koeln, Germany
HELIOS Kliniken - HELIOS Klinik Rottweil
🇩🇪Rottweil, Germany
Kliniken Landkreis Sigmaringen GmbH
🇩🇪Sigmaringen, Germany
Oxford University Hospitals NHS Trust - Churchill Hospital
🇬🇧Oxford, United Kingdom
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinikum Traunstein
🇩🇪Traunstein, Germany
Gesundheitszentren Rhein-Neckar - GRN-Klinik Weinheim
🇩🇪Weinheim, Germany
Medizinischen Zentrum Bonn
🇩🇪Bonn, Germany
Hopital Universitaire Brugmann
🇧🇪Brussels, Belgium
Onze Lieve Vrouw Ziekenhuis
🇧🇪Aalst, Belgium
Hopital De Jolimont
🇧🇪Haine St Paul, Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Centre Regional Francois Baclesse
🇫🇷Caen, France
U.Z. Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier Departemental Vendée
🇫🇷La Roche Sur Yon, France
Centre Hospitalier de Mont-de-Marsan
🇫🇷Mont-de-Marsan, France
Institut Curie
🇫🇷Paris, France
Institut Curie - Hopital Rene Huguenin
🇫🇷Saint-Cloud, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre-Les-Nancy, France
Klinikum Sindelfingen-Boeblingen
🇩🇪Boeblingen, Germany
Gemeinschaftspraxis Lorenz / Hecker / Wesche
🇩🇪Braunschweig, Germany
Staedtische Kliniken
🇩🇪Esslingen, Germany
Ev.-Luth. Diakonissenanstalt Flensburg
🇩🇪Flensburg, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
Gemeinschaftspraxis Dr. Goldmann/ Dr. Ebert
🇩🇪Lueneburg, Germany
Ludwig-Maximilians-Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Innenstadt
🇩🇪Muenchen, Germany
Studienzentrum Onkologie Ravensburg
🇩🇪Ravensburg, Germany
HELIOS Kliniken - HELIOS Brustzentrums Nordachsen - HELIOS Klinik Schkeuditz
🇩🇪Schkeuditz, Germany
Eberhard Karls Universitaet Tuebingen - Universitaetsfrauenklinik Tuebingen
🇩🇪Tuebingen, Germany
Onkologische Schwerpunktpraxis Wupperta
🇩🇪Wuppertal, Germany