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Brief Title: DESTINY Breast Respond HER2-low Europe
Official Title: A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-low Europe)
Study ID: NCT05945732
Brief Summary: Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Detailed Description: This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medizinische Universität Graz, Graz, , Austria
Medizinische Universität Graz, Graz, , Austria
Medizinische Universität Innsbruck, Innsbruck, , Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, , Austria
Interne II, LKH Feldkirch, Rankweil, , Austria
KH der Barmherzigen Brüder Salzburg, Salzburg, , Austria
Uniklinikum Salzburg, Salzburg, , Austria
Salzkammergut Klinikum Vöcklabruck, Vöcklabruck, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
Landesklinikum Wiener Neustadt, Wiener Neustadt, , Austria
Medical University of Vienna, Wien, , Austria
Medizinische Universität Wien, Wien, , Austria
Krankenhaus Hietzing, Wien, , Austria
ASZ Aalst, Aalst, , Belgium
Imeldaziekenhuis Bonheiden, Bonheiden, , Belgium
AZ Klina, Brasschaat, , Belgium
AZ Sint-Jan Brugge av, Brugge, , Belgium
CHU Brugmann, Brussels, , Belgium
Cliniques universitaires Saint-Luc, Brussels, , Belgium
Chu Helora- Hôpital de La Louvière- site Jolimont, Haine Saint Paul, , Belgium
CHU Tivoli, La Louviere, , Belgium
Hôpital de la Citadelle, Liege, , Belgium
CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium
Clinique Saint Pierre Ottignies, Ottignies, , Belgium
VITAZ, Sint-Niklaas, , Belgium
CHR Verviers East Belgium, Verviers, , Belgium
Aalborg Universitetshospital, Syd, Aalborg, , Denmark
Aarhus University Hospital, Aarhus N, , Denmark
Sygehus Sønderjylland, Sønderborg, Sønderborg, , Denmark
CHU Amiens Picardie, Amiens, , France
Clinique de l'Europe, Amiens, , France
Institut du Cancer Avignon Provence, Avignon, , France
CH Cote Basque, Bayonne, , France
Clinique Belharra, Bayonne, , France
Chu Jean Minjoz Besancon, Besançon, , France
Clinique Tivoli-Ducos, Bordeaux, , France
Centre hospitalier Fleyriat, Bourg-en-Bresse, , France
Centre Francois Baclesse, Caen, , France
Centre Hospitalier William Morey, Chalon-sur-Saône, , France
Pole Sante Leonard De Vinci, Chambray-lès-Tours, , France
CH Metropole Savoie, Chambéry, , France
CH Cholet, Cholet, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Polyclinique St Côme, Compiègne, , France
Hôpital Henri Mondor, Créteil, , France
Centre Léonard de Vinci, Dechy, , France
Centre Georges Francois Leclerc, Dijon, , France
CHU Martinique, Fort De France Cedex, , France
CHI Frejus Saint Raphael, Fréjus, , France
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH), Grenoble, , France
Polyclinique De Blois, La Chaussee Saint Victor, , France
La Tronche - CHU Grenoble, La Tronche, , France
Centre de cancerologie de la Sarthe, Le Mans, , France
Centre Hospitalier Emile Roux, Le Puy-en-Velay, , France
Centre Oscar Lambret, Lille, , France
CHU Lille, Lille, , France
Hôpital Prive Le Bois, Lille, , France
Hospices Civils De Lyon, Lyon, , France
Hôpital-Clinique Claude Bernard, Metz, , France
GH Havre, Montivilliers, , France
Clinique Clementville, Montpellier, , France
Groupe Hospitalier privé Ambroise Pare Hartmann, Neuilly-sur-Seine, , France
Hopital Americain de Paris, Neuilly-sur-Seine, , France
Centre Antoine Lacassagne, Nice, , France
Centre Hospitalier de Niort, Niort, , France
Centre Médical ONCOGARD, NÎMES Cedex 9, , France
Institut Curie, Paris, , France
Groupement Hospitalier Diaconesses Croix Saint Simon, Paris, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hôpital Saint Joseph, Paris, , France
CHU Poitiers, Poitiers, , France
Institut Godinot, Reims, , France
Polyclinique Courlancy, Reims, , France
Clinique Saint Hilaire, Rouen, , France
Clinique Mathilde, Rouen, , France
Saint Cloud -Rene Huguenin Institut Curie, Saint-Cloud, , France
CHU Réunion Site Sud, Saint-Paul, , France
Institut De Cancerologie Paris Nord, Sarcelles, , France
Centre Hospitalier de Sens, Sens Cédex, , France
Hôpital Foch, Suresnes, , France
CHR Metz Thionville, Thionville, , France
HIA Sainte-Anne, Toulon, , France
Centre Hospitalier de Troyes, Troyes, , France
Hopital Prive Drome Ardeche, Valence, , France
Nouvelle Clinique Des Dentellières, Valenciennes, , France
Institut De Cancerologie De Lorraine, Vandœuvre-lès-Nancy, , France
Médipôle Hôpital Mutualiste, Villeurbanne, , France
Azienda Ospedaliera di Alessandria, Alessandria, , Italy
Ospedale SS Annunziata, Chieti, , Italy
Ospedale Citta' di Castello USL Umbria 1, Città di Castello, , Italy
Ospedale San Giuseppe - Azienda USL Toscana Centro, Empoli, , Italy
ASST Lecco - PO "Alessandro Manzoni", Lecco, , Italy
AULSS 9 Scaligera - Ospedale Mater Salutis, Legnago, , Italy
Ospedale Generale Provinciale di Macerata, Macerata, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS, Meldola, , Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, , Italy
AOU Federico II, Napoli, , Italy
AOU Maggiore della Carità di Novara, Novara, , Italy
IOV - Istituto Oncologico Veneto - IRCCS, Padova, , Italy
ARNAS Ospedale Civico e Benfratelli, Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, , Italy
AO Regionale San Carlo, Potenza, , Italy
ASL RM 2 Ospedale Pertini, Roma, , Italy
AO San Giovanni Addolorata, Roma, , Italy
AOU "San Giovanni di Dio e Ruggi d'Aragona", Salerno, , Italy
Ospedale San Vincenzo, Taormina, , Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette, Torino, , Italy
AO Ordine Mauriziano, Torino, , Italy
ASUFC Udine - Santa Maria della Misericordia, Udine, , Italy
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi ", Varese, , Italy
Universitetssjukhuset Nord-Norge, Tromsø, , Norway
Hospital Clinico Universitario de Albacete, Albacete, , Spain
Hospital Universitario de La Ribera, Alzira, , Spain
Hospital Universitario de Basurto, Bilbao, , Spain
Hospital Universitario Reina Sofia, Cordoba, , Spain
Hospital Universitario San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario de Puerto Real, Cádiz, , Spain
Hospital Clinico Universitario de Granada (PTS), Granada, , Spain
Hospital Universitario de Canarias, La Laguna, , Spain
Complejo Asistencial Universitario de León, León, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico Universitario San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital de Getafe, Madrid, , Spain
Hospital Virgen Arrixaca de Murcia, Murcia, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Son Espases, Palma de Mallorca, , Spain
Hospital Son Llatzer, Palma, , Spain
Hospital de Pontevedra, Pontevedra, , Spain
Hospital San Joan de Reus, Reus, , Spain
Hospital Universitari Parc Taulí, Sabadell, , Spain
Hospital General de Catalunya, Sant Cugat del Vallès, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario General de Valencia, Valencia, , Spain
Hospital Clínico de Valladolid, Valladolid, , Spain
Complejo Hospitalario Universitario De Vigo, Vigo Pontevedra, , Spain
Capio St Görans sjukhus, Stockholm, , Sweden
Bröstcentrum, Karolinska Universitetssjukhuset Solna, Stockholm, , Sweden
Department of Oncology, Västerås, Västerås, , Sweden
Department of Oncology, Örebro University Hospital, Örebro, , Sweden
Kantonsspital Baden, Baden, , Switzerland
Spital Thurgau AG - Kantonsspital Frauenfeld, Frauenfeld, , Switzerland
Centre du sein Fribourg, Fribourg, , Switzerland
Clinique Generale-Beaulieu / Clinique de Genolier, Genève, , Switzerland
CHUV, Lausanne, , Switzerland
Hôpital du Valais Sion, Sion, , Switzerland
ZIO AG, Zürich, , Switzerland
Name: Global Team Leader
Affiliation: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Role: STUDY_DIRECTOR