DESTINY Breast Respond HER2-low Europe

Last updated: April 3, 2025
Sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metastatic Cancer

Breast Cancer

Treatment

Trastuzumab deruxtecan

Clinical Study ID

NCT05945732
DS8201-0005-NIS-MA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosisof unresectable and/or mBC

  • Documented HER2-low status (IHC1+, IHC2+/ISH-)

  • Patients who have received prior chemotherapy in the metastatic setting or patientswho have developed disease recurrence during or within 6 months of completingadjuvant chemotherapy

  • Decision to newly initiate therapy of T-DXd or conventional chemotherapy accordingto the physicians choice per SmPC

  • Written and signed Informed Consent to participate in the study

Exclusion

Exclusion Criteria:

  • Pregnancy or breastfeeding

  • Patients who at time of data collection for this study are participating in or haveparticipated in an interventional study that remains blinded.

No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

Study Design

Total Participants: 1350
Treatment Group(s): 1
Primary Treatment: Trastuzumab deruxtecan
Phase:
Study Start date:
October 24, 2023
Estimated Completion Date:
September 01, 2028

Study 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.

Connect with a study center

  • Medizinische Universität Graz

    Graz, 8036
    Austria

    Terminated

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt am Wörthersee, 9020
    Austria

    Active - Recruiting

  • LKH Hochsteiermark-Leoben

    Leoben, 8700
    Austria

    Site Not Available

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010
    Austria

    Active - Recruiting

  • Interne II, LKH Feldkirch

    Rankweil, 6830
    Austria

    Active - Recruiting

  • KH der Barmherzigen Brüder Salzburg

    Salzburg, 5010
    Austria

    Active - Recruiting

  • Uniklinikum Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Salzkammergut Klinikum Vöcklabruck

    Vöcklabruck, 4840
    Austria

    Active - Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600
    Austria

    Active - Recruiting

  • Krankenhaus Hietzing

    Wien, 1130
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Wien, 1090
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Terminated

  • Landesklinikum Wiener Neustadt

    Wiener Neustadt, 2700
    Austria

    Active - Recruiting

  • ASZ Aalst

    Aalst, 9300
    Belgium

    Active - Recruiting

  • Chirec Delta Hospital

    Auderghem, 1160
    Belgium

    Site Not Available

  • Imeldaziekenhuis Bonheiden

    Bonheiden, 2820
    Belgium

    Active - Recruiting

  • AZ Klina

    Brasschaat, 2930
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge av

    Brugge, 8000
    Belgium

    Active - Recruiting

  • CHU Brugmann

    Brussels, 1020
    Belgium

    Active - Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Active - Recruiting

  • Chu Helora- Hôpital de La Louvière- site Jolimont

    Haine Saint Paul, 7100
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • CHU Tivoli

    La Louviere, 7100
    Belgium

    Active - Recruiting

  • Hôpital de la Citadelle

    Liege, 4000
    Belgium

    Active - Recruiting

  • CHC MontLegia

    Liège, 4000
    Belgium

    Site Not Available

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, B5000
    Belgium

    Active - Recruiting

  • Clinique Saint Pierre Ottignies

    Ottignies, 1340
    Belgium

    Active - Recruiting

  • VITAZ

    Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • CHR Verviers East Belgium

    Verviers, 4800
    Belgium

    Active - Recruiting

  • Aalborg Universitetshospital, Syd

    Aalborg, 9000
    Denmark

    Terminated

  • Aarhus University Hospital

    Aarhus N, 8200
    Denmark

    Active - Recruiting

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Active - Recruiting

  • Onkologisk og Palliativ afdeling, Nordsjællands Hospital

    Hillerød, 3400
    Denmark

    Site Not Available

  • Naestved Hospital

    Naestved, 4700
    Denmark

    Site Not Available

  • Sygehus Sønderjylland, Sønderborg

    Sønderborg, 6400
    Denmark

    Terminated

  • CHU Amiens Picardie

    Amiens, 80000
    France

    Active - Recruiting

  • Clinique de l'Europe

    Amiens, 80090
    France

    Active - Recruiting

  • Hôpital Privé d'Antony

    Antony, 92160
    France

    Site Not Available

  • Hôpital Privé les Bonnettes

    Arras, 62000
    France

    Site Not Available

  • Institut du Cancer Avignon Provence

    Avignon, 84918
    France

    Active - Recruiting

  • CH Cote Basque

    Bayonne, 64100
    France

    Active - Recruiting

  • Clinique Belharra

    Bayonne, 64100
    France

    Active - Recruiting

  • Chu Jean Minjoz Besancon

    Besançon, 25000
    France

    Active - Recruiting

  • Clinique Tivoli-Ducos

    Bordeaux, 33000
    France

    Active - Recruiting

  • Centre hospitalier Fleyriat

    Bourg-en-Bresse, 01012
    France

    Active - Recruiting

  • Centre Francois Baclesse

    Caen, 14000
    France

    Site Not Available

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71321
    France

    Active - Recruiting

  • Pole Sante Leonard De Vinci

    Chambray-lès-Tours, 37170
    France

    Active - Recruiting

  • CH Metropole Savoie

    Chambéry, 73000
    France

    Active - Recruiting

  • CH Cholet

    Cholet, 49300
    France

    Active - Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Polyclinique St Côme

    Compiègne, 60200
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • Centre Léonard de Vinci

    Dechy, 59187
    France

    Active - Recruiting

  • Centre Georges Francois Leclerc

    Dijon, 21000
    France

    Site Not Available

  • CHU Martinique

    Fort De France Cedex, 97261
    France

    Site Not Available

  • CHI Frejus Saint Raphael

    Fréjus, 83600
    France

    Active - Recruiting

  • Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)

    Grenoble, 38000
    France

    Active - Recruiting

  • Polyclinique De Blois

    La Chaussee Saint Victor, 41260
    France

    Active - Recruiting

  • La Tronche - CHU Grenoble

    La Tronche, 38700
    France

    Active - Recruiting

  • Centre de cancerologie de la Sarthe

    Le Mans, 72100
    France

    Site Not Available

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay, 43000
    France

    Active - Recruiting

  • Hôpital Franco-Britannique Cognac Jay

    Levallois-Perret, 92300
    France

    Site Not Available

  • CHU Lille

    Lille, 59000
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59000
    France

    Site Not Available

  • Hôpital Prive Le Bois

    Lille, 59000
    France

    Active - Recruiting

  • CHU de Limoges

    Limoges, 87042
    France

    Site Not Available

  • Hospices Civils De Lyon

    Lyon, 69002
    France

    Active - Recruiting

  • Hôpital Jean Mermoz

    Lyon, 69008
    France

    Site Not Available

  • Hôpital-Clinique Claude Bernard

    Metz, 57070
    France

    Site Not Available

  • GH Havre

    Montivilliers, 76920
    France

    Active - Recruiting

  • Clinique Clementville

    Montpellier, 34070
    France

    Active - Recruiting

  • Groupe Hospitalier privé Ambroise Pare Hartmann

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Hopital Americain de Paris

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06100
    France

    Active - Recruiting

  • Centre Hospitalier de Niort

    Niort, 79000
    France

    Active - Recruiting

  • Centre Médical ONCOGARD

    NÎMES Cedex 9, 30029
    France

    Active - Recruiting

  • Groupement Hospitalier Diaconesses Croix Saint Simon

    Paris, 75012
    France

    Active - Recruiting

  • Hopital Europeen Georges Pompidou

    Paris, 75015
    France

    Site Not Available

  • Hôpital Saint Joseph

    Paris, 75103
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Centre Hospitalier de Pau

    Pau, 64000
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers, 86000
    France

    Active - Recruiting

  • Institut Godinot

    Reims, 51100
    France

    Active - Recruiting

  • Polyclinique Courlancy

    Reims, 51100
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Site Not Available

  • Clinique Mathilde

    Rouen, 76100
    France

    Active - Recruiting

  • Clinique Saint Hilaire

    Rouen, 76000
    France

    Site Not Available

  • Saint Cloud -Rene Huguenin Institut Curie

    Saint-Cloud, 92210
    France

    Site Not Available

  • CHU Réunion Site Sud

    Saint-Paul, 97460
    France

    Active - Recruiting

  • Institut De Cancerologie Paris Nord

    Sarcelles, 95200
    France

    Site Not Available

  • Centre Hospitalier de Sens

    Sens Cédex, 89108
    France

    Active - Recruiting

  • Hôpital Foch

    Suresnes, 92150
    France

    Site Not Available

  • CHR Metz Thionville

    Thionville, 57100
    France

    Active - Recruiting

  • HIA Sainte-Anne

    Toulon, 83000
    France

    Site Not Available

  • Centre Hospitalier de Troyes

    Troyes, 10000
    France

    Site Not Available

  • Hopital Prive Drome Ardeche

    Valence, 26000
    France

    Active - Recruiting

  • Nouvelle Clinique Des Dentellières

    Valenciennes, 59300
    France

    Active - Recruiting

  • Institut De Cancerologie De Lorraine

    Vandœuvre-lès-Nancy, 54519
    France

    Site Not Available

  • Centre d'oncologie Saint-Yves

    Vannes, 56000
    France

    Site Not Available

  • Médipôle Hôpital Mutualiste

    Villeurbanne, 69100
    France

    Site Not Available

  • Azienda Ospedaliera di Alessandria

    Alessandria, 15121
    Italy

    Active - Recruiting

  • Ospedale SS Annunziata

    Chieti, 66100
    Italy

    Active - Recruiting

  • Ospedale Citta' di Castello USL Umbria 1

    Città di Castello, 06012
    Italy

    Active - Recruiting

  • Ospedale San Giuseppe - Azienda USL Toscana Centro

    Empoli, 50053
    Italy

    Active - Recruiting

  • ASL Lecce - Ospedale "Vito Fazzi"

    Lecce, 42100
    Italy

    Active - Recruiting

  • ASST Lecco - PO "Alessandro Manzoni"

    Lecco, 23900
    Italy

    Active - Recruiting

  • AULSS 9 Scaligera - Ospedale Mater Salutis

    Legnago, 37045
    Italy

    Active - Recruiting

  • ASST Ovest Milanese - Ospedale di Legnano

    Legnano, 90146
    Italy

    Active - Recruiting

  • Ospedale Generale Provinciale di Macerata

    Macerata, 62100
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

    Meldola, 47014
    Italy

    Active - Recruiting

  • AOU di Modena

    Modena, 73100
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, 20900
    Italy

    Active - Recruiting

  • AOU Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • AOU Maggiore della Carità di Novara

    Novara, 28100
    Italy

    Active - Recruiting

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, 35128
    Italy

    Active - Recruiting

  • ARNAS Ospedale Civico e Benfratelli

    Palermo, 90124
    Italy

    Active - Recruiting

  • La Maddalena S.p.A.

    Palermo, 41124
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • AOU Pisana - Stabilimento Santa Chiara

    Pisa, 89133
    Italy

    Active - Recruiting

  • AO Regionale San Carlo

    Potenza, 85100
    Italy

    Active - Recruiting

  • GOM "BMM" - Presidio Ospedaliero Morelli

    Reggio Calabria, 20025
    Italy

    Active - Recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, 31100
    Italy

    Active - Recruiting

  • AO San Giovanni Addolorata

    Roma, 00184
    Italy

    Active - Recruiting

  • ASL RM 2 Ospedale Pertini

    Roma, 00157
    Italy

    Active - Recruiting

  • AOU "San Giovanni di Dio e Ruggi d'Aragona"

    Salerno, 84135
    Italy

    Active - Recruiting

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Active - Recruiting

  • AOU Sassari - Ospedale Civile SS. Annunziata

    Sassari, 56126
    Italy

    Active - Recruiting

  • Ospedale San Vincenzo

    Taormina, 98039
    Italy

    Active - Recruiting

  • AO Ordine Mauriziano

    Torino, 10128
    Italy

    Active - Recruiting

  • AOU Città della Salute e della Scienza di Torino - Ospedale Molinette

    Torino, 10126
    Italy

    Active - Recruiting

  • AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"

    Treviso, 28100
    Italy

    Active - Recruiting

  • ASUFC Udine - Santa Maria della Misericordia

    Udine, 33100
    Italy

    Active - Recruiting

  • ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "

    Varese, 22100
    Italy

    Active - Recruiting

  • Nordlandssjukhuset Bodø

    Bodø, 8005
    Norway

    Active - Recruiting

  • Drammen Sykehus

    Drammen, 3004
    Norway

    Active - Recruiting

  • Sørlandet sykehus / Kristiansand Hospital

    Kristiansand, 4615
    Norway

    Active - Recruiting

  • Sykehuset Telemark

    Skien, 3710
    Norway

    Active - Recruiting

  • Universitetssjukhuset Nord-Norge

    Tromsø, 9019
    Norway

    Active - Recruiting

  • Hospital Clinico Universitario de Albacete

    Albacete, 02006
    Spain

    Site Not Available

  • Hospital Universitario de La Ribera

    Alzira, 46600
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, 48903
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026
    Spain

    Site Not Available

  • Hospital Universitario de Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario San Pedro de Alcántara

    Cáceres, 10003
    Spain

    Site Not Available

  • Hospital Universitario de Puerto Real

    Cádiz, 11510
    Spain

    Active - Recruiting

  • Hospital General Universitario de Elche

    Elche, 03203
    Spain

    Site Not Available

  • Hospital de Galdakao

    Galdakao, 48960
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Granada (PTS)

    Granada, 18016
    Spain

    Active - Recruiting

  • Hospital Universitario Médico-Quirúrgico de Jaén

    Jaén, 23007
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    La Laguna, 38320
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de León

    León, 24008
    Spain

    Site Not Available

  • Hospital Universitario San Pedro de Logroño

    Logroño, 26006
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo, 270003
    Spain

    Site Not Available

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario la Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital de Getafe

    Madrid, 28905
    Spain

    Active - Recruiting

  • Hospital Virgen Arrixaca de Murcia

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 330011
    Spain

    Active - Recruiting

  • Complejo Asistencial Universitario de Palencia

    Palencia, 34005
    Spain

    Site Not Available

  • Hospital Son Llatzer

    Palma, 07198
    Spain

    Site Not Available

  • Hospital Son Espases

    Palma de Mallorca, 07210
    Spain

    Site Not Available

  • Hospital de Pontevedra

    Pontevedra, 36001
    Spain

    Active - Recruiting

  • Hospital San Joan de Reus

    Reus, 43204
    Spain

    Site Not Available

  • Hospital Universitari Parc Taulí

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hospital General de Catalunya

    Sant Cugat del Vallès, 08195
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario General de Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Hospital Clínico de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Universitario Rio Hortega

    Valladolid, 47012
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario De Vigo

    Vigo Pontevedra, 36312
    Spain

    Active - Recruiting

  • Onkologikliniken Mälarsjukhuset

    Eskilstuna, 63188
    Sweden

    Active - Recruiting

  • Gävle Hospital

    Gävle, 80324
    Sweden

    Active - Recruiting

  • Ryhov County Hospital

    Jönköping, 55185
    Sweden

    Active - Recruiting

  • Bröstcentrum, Karolinska Universitetssjukhuset Solna

    Stockholm, 17176
    Sweden

    Active - Recruiting

  • Capio St Görans sjukhus

    Stockholm, 11912
    Sweden

    Active - Recruiting

  • Onkologkliniken Sundsvalls Sjukhus

    Sundsvall, 85643
    Sweden

    Site Not Available

  • Cancercentrum, Norrlands Universitetssjukhus

    Umeå, 901 85
    Sweden

    Site Not Available

  • Department of Oncology, Västerås

    Västerås, 72335
    Sweden

    Active - Recruiting

  • Department of Oncology, Örebro University Hospital

    Örebro, 70185
    Sweden

    Active - Recruiting

  • Kantonsspital Baden

    Baden, 5404
    Switzerland

    Active - Recruiting

  • Spital Thurgau AG - Kantonsspital Frauenfeld

    Frauenfeld, 8500
    Switzerland

    Active - Recruiting

  • Centre du sein Fribourg

    Fribourg, 1701
    Switzerland

    Active - Recruiting

  • Clinique Generale-Beaulieu / Clinique de Genolier

    Genève, 1206
    Switzerland

    Active - Recruiting

  • Réseau Hospitalier Neuchâtelois (RHNe)

    La Chaux-de-Fonds, 2300
    Switzerland

    Active - Recruiting

  • CHUV

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Réseau du Sein Lausanne

    Lausanne, 1003
    Switzerland

    Active - Recruiting

  • Kantonsspital Baselland

    Liestal, 4410
    Switzerland

    Active - Recruiting

  • Hôpital du Valais Sion

    Sion, 1951
    Switzerland

    Active - Recruiting

  • Kantonsspital St.Gallen

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Active - Recruiting

  • ZIO AG

    Zürich, 8005
    Switzerland

    Active - Recruiting

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