DESTINY Breast Respond HER2-low Europe

February 9, 2026 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Drug: Trastuzumab deruxtecan

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.

Study Type

Observational

Enrollment (Estimated)

1155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Contact for Clinical Trial Information
Phone Number: 908-992-6400
Email: CTRinfo@dsi.com

Study Locations

Austria
- - Graz, Austria, 8036
    - Terminated
    - Medizinische Universität Graz
  - Graz, Austria, 8036
    - Active, not recruiting
    - Medizinische Universität Graz
  - Innsbruck, Austria, 6020
    - Active, not recruiting
    - Medizinische Universität Innsbruck
  - Klagenfurt, Austria, 9020
    - Active, not recruiting
    - Klinikum Klagenfurt Am Wörthersee
  - Leoben, Austria, 8700
    - Withdrawn
    - Lkh Hochsteiermark-Leoben
  - Linz, Austria, 4010
    - Active, not recruiting
    - Ordensklinikum Linz GmbH Barmherzige Schwestern
  - Rankweil, Austria, 6830
    - Active, not recruiting
    - Interne II, LKH Feldkirch
  - Salzburg, Austria, 5020
    - Active, not recruiting
    - Uniklinikum Salzburg
  - Salzburg, Austria, 5010
    - Active, not recruiting
    - KH der Barmherzigen Brüder Salzburg
  - Vienna, Austria, 1090
    - Active, not recruiting
    - Medical University of Vienna
  - Vienna, Austria, 1090
    - Terminated
    - Medizinische Universität Wien
  - Vienna, Austria, 1130
    - Active, not recruiting
    - Krankenhaus Hietzing
  - Vöcklabruck, Austria, 4840
    - Active, not recruiting
    - Salzkammergut Klinikum Vöcklabruck
  - Wels, Austria, 4600
    - Active, not recruiting
    - Klinikum Wels-Grieskirchen GmbH
  - Wiener Neustadt, Austria, 2700
    - Active, not recruiting
    - Landesklinikum Wiener Neustadt
Belgium
- - Aalst, Belgium, 9300
    - Active, not recruiting
    - ASZ Aalst
  - Auderghem, Belgium, 1160
    - Active, not recruiting
    - Chirec Delta Hospital
  - Bonheiden, Belgium, 2820
    - Active, not recruiting
    - Imeldaziekenhuis Bonheiden
  - Brasschaat, Belgium, 2930
    - Active, not recruiting
    - AZ Klina
  - Bruges, Belgium, 8000
    - Active, not recruiting
    - AZ Sint-Jan Brugge AV
  - Brussels, Belgium, 1200
    - Active, not recruiting
    - Cliniques Universitaires Saint-Luc
  - Brussels, Belgium, 1020
    - Active, not recruiting
    - CHU Brugmann
  - Haine-Saint-Paul, Belgium, 7100
    - Active, not recruiting
    - Chu Helora- Hôpital de La Louvière- site Jolimont
  - Hasselt, Belgium, 3500
    - Active, not recruiting
    - Jessa Ziekenhuis
  - La Louvière, Belgium, 7100
    - Active, not recruiting
    - CHU Tivoli
  - Liège, Belgium, 4000
    - Active, not recruiting
    - CHC MontLegia
  - Liège, Belgium, 4000
    - Active, not recruiting
    - Hôpital de la Citadelle
  - Namur, Belgium, B5000
    - Active, not recruiting
    - CHU UCL Namur/Site Sainte Elisabeth
  - Ottignies, Belgium, 1340
    - Active, not recruiting
    - Clinique Saint Pierre Ottignies
  - Sint-Niklaas, Belgium, 9100
    - Active, not recruiting
    - Vitaz
  - Verviers, Belgium, 4800
    - Active, not recruiting
    - CHR Verviers East Belgium
Denmark
- - Aalborg, Denmark, 9000
    - Terminated
    - Aalborg Universitetshospital, Syd
  - Aarhus N, Denmark, 8200
    - Recruiting
    - Aarhus University Hospital
    - Contact:
      
      Principal Investigator
  - Herlev, Denmark, 2730
    - Recruiting
    - Herlev Hospital
    - Contact:
      
      Principal Investigator
  - Hillerød, Denmark, 3400
    - Recruiting
    - Onkologisk og Palliativ afdeling, Nordsjællands Hospital
    - Contact:
      
      Principal Investigator
  - Næstved, Denmark, 4700
    - Recruiting
    - Naestved Hospital
    - Contact:
      
      Principal Investigator
  - Sønderborg, Denmark, 6400
    - Terminated
    - Sygehus Sønderjylland, Sønderborg
France
- - Amiens, France, 80090
    - Recruiting
    - Clinique de l'Europe
    - Contact:
      
      Principal Investigator
  - Amiens, France, 80000
    - Active, not recruiting
    - CHU Amiens Picardie
  - Antony, France, 92160
    - Recruiting
    - Hopital Prive d'Antony
    - Contact:
      
      Principal Investigator
  - Arras, France, 62000
    - Recruiting
    - Hôpital Privé les Bonnettes
    - Contact:
      
      Principal Investigator
  - Avignon, France, 84918
    - Recruiting
    - Institut du Cancer Avignon Provence
    - Contact:
      
      Principal Investigator
  - Bayonne, France, 64100
    - Recruiting
    - CH Côte Basque
    - Contact:
      
      Principal Investigator
  - Bayonne, France, 64100
    - Withdrawn
    - Clinique Belharra
  - Besançon, France, 25000
    - Active, not recruiting
    - Chu Jean Minjoz Besancon
  - Bordeaux, France, 33000
    - Recruiting
    - Clinique TIVOLI-DUCOS
    - Contact:
      
      Principal Investigator
  - Bourg-en-Bresse, France, 01012
    - Recruiting
    - Centre Hospitalier Fleyriat
    - Contact:
      
      Principal Investigator
  - Caen, France, 14000
    - Recruiting
    - Centre Francois Baclesse
    - Contact:
      
      Principal Investigator
  - Chalon-sur-Saône, France, 71321
    - Recruiting
    - Centre Hospitalier William Morey
    - Contact:
      
      Principal Investigator
  - Chambray-lès-Tours, France, 37170
    - Recruiting
    - Pôle Santé Léonard de Vinci
    - Contact:
      
      Principal Investigator
  - Chambéry, France, 73000
    - Recruiting
    - CH Métropole Savoie
    - Contact:
      
      Principal Investigator
  - Cholet, France, 49300
    - Recruiting
    - CH Cholet
    - Contact:
      
      Principal Investigator
  - Clermont-Ferrand, France, 63011
    - Recruiting
    - Centre Jean Perrin
    - Contact:
      
      Principal Investigator
  - Compiègne, France, 60200
    - Recruiting
    - Polyclinique St Côme
    - Contact:
      
      Principal Investigator
  - Créteil, France, 94000
    - Recruiting
    - Hopital Henri Mondor
    - Contact:
      
      Principal Investigator
  - Dechy, France, 59187
    - Recruiting
    - Centre Leonard de Vinci
    - Contact:
      
      Principal Investigator
  - Dijon, France, 21000
    - Recruiting
    - Centre Georges François Leclerc
    - Contact:
      
      Principal Investigator
  - Fort de France Cedex, France, 97261
    - Recruiting
    - CHU Martinique
    - Contact:
      
      Principal Investigator
  - Fréjus, France, 83600
    - Recruiting
    - CHI Frejus Saint Raphael
    - Contact:
      
      Principal Investigator
  - Grenoble, France, 38000
    - Recruiting
    - Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
    - Contact:
      
      Principal Investigator
  - La Chaussée-Saint-Victor, France, 41260
    - Recruiting
    - Polyclinique de Blois
    - Contact:
      
      Principal Investigator
  - La Tronche, France, 38700
    - Recruiting
    - La Tronche - CHU Grenoble
    - Contact:
      
      Principal Investigator
  - Le Mans, France, 72100
    - Recruiting
    - Centre de Cancérologie de la Sarthe
    - Contact:
      
      Principal Investigator
  - Le Puy-en-Velay, France, 43000
    - Recruiting
    - Centre Hospitalier Emile Roux
    - Contact:
      
      Principal Investigator
  - Levallois-Perret, France, 92300
    - Recruiting
    - Hopital Franco-Britannique Cognac Jay
    - Contact:
      
      Principal Investigator
  - Lille, France, 59000
    - Recruiting
    - Centre Oscar Lambret
    - Contact:
      
      Principal Investigator
  - Lille, France, 59000
    - Recruiting
    - Hôpital Privé Le Bois
    - Contact:
      
      Principal Investigator
  - Lille, France, 59000
    - Recruiting
    - CHU Lille
    - Contact:
      
      Principal Investigator
  - Limoges, France, 87042
    - Recruiting
    - CHU de Limoges
    - Contact:
      
      Principal Investigator
  - Lyon, France, 69008
    - Recruiting
    - Hôpital Jean Mermoz
    - Contact:
      
      Principal Investigator
  - Lyon, France, 69002
    - Active, not recruiting
    - Hospices civils de Lyon
  - Metz, France, 57070
    - Withdrawn
    - Hôpital-Clinique Claude Bernard
  - Montivilliers, France, 76920
    - Recruiting
    - GH Havre
    - Contact:
      
      Principal Investigator
  - Montpellier, France, 34070
    - Recruiting
    - Clinique Clémentville
    - Contact:
      
      Principal Investigator
  - Neuilly-sur-Seine, France, 92200
    - Recruiting
    - Hôpital Américain de Paris
    - Contact:
      
      Principal Investigator
  - Neuilly-sur-Seine, France, 92200
    - Recruiting
    - Groupe Hospitalier privé Ambroise Pare Hartmann
    - Contact:
      
      Principal Investigator
  - Nice, France, 06100
    - Recruiting
    - Centre Antoine Lacassagne
    - Contact:
      
      Principal Investigator
  - Niort, France, 79000
    - Recruiting
    - Centre Hospitalier de Niort
    - Contact:
      
      Principal Investigator
  - Nîmes, France, 30029
    - Recruiting
    - Centre médical Oncogard
    - Contact:
      
      Principal Investigator
  - Paris, France, 75005
    - Recruiting
    - Institut Curie
    - Contact:
      
      Principal Investigator
  - Paris, France, 75015
    - Recruiting
    - Hôpital Européen Georges Pompidou
    - Contact:
      
      Principal Investigator
  - Paris, France, 75012
    - Recruiting
    - Groupement Hospitalier Diaconesses Croix Saint Simon
    - Contact:
      
      Principal Investigator
  - Paris, France, 75103
    - Recruiting
    - Hopital Saint Joseph
    - Contact:
      
      Principal Investigator
  - Pau, France, 64000
    - Recruiting
    - Centre Hospitalier De Pau
    - Contact:
      
      Principal Investigator
  - Poitiers, France, 86000
    - Recruiting
    - CHU Poitiers
    - Contact:
      
      Principal Investigator
  - Reims, France, 51100
    - Recruiting
    - Institut Godinot
    - Contact:
      
      Principal Investigator
  - Reims, France, 51100
    - Recruiting
    - Polyclinique Courlancy
    - Contact:
      
      Principal Investigator
  - Rennes, France, 35042
    - Recruiting
    - Centre Eugène Marquis
    - Contact:
      
      Principal Investigator
  - Rouen, France, 76100
    - Recruiting
    - Clinique Mathilde
    - Contact:
      
      Principal Investigator
  - Rouen, France, 76000
    - Withdrawn
    - Clinique Saint Hilaire
  - Saint-Cloud, France, 92210
    - Withdrawn
    - Saint Cloud -Rene Huguenin Institut Curie
  - Saint-Paul, France, 97460
    - Recruiting
    - CHU REUNION site SUD
    - Contact:
      
      Principal Investigator
  - Sarcelles, France, 95200
    - Recruiting
    - Institut de Cancérologie Paris Nord
    - Contact:
      
      Principal Investigator
  - Sens Cédex, France, 89108
    - Recruiting
    - Centre Hospitalier de Sens
    - Contact:
      
      Principal Investigator
  - Suresnes, France, 92150
    - Recruiting
    - Hôpital Foch
    - Contact:
      
      Principal Investigator
  - Thionville, France, 57100
    - Recruiting
    - CHR Metz Thionville
    - Contact:
      
      Principal Investigator
  - Toulon, France, 83000
    - Recruiting
    - HIA Sainte-Anne
    - Contact:
      
      Principal Investigator
  - Troyes, France, 10000
    - Withdrawn
    - Centre Hospitalier de Troyes
  - Valence, France, 26000
    - Recruiting
    - Hopital Prive Drome Ardeche
    - Contact:
      
      Principal Investigator
  - Valenciennes, France, 59300
    - Recruiting
    - Nouvelle Clinique des Dentellières
    - Contact:
      
      Principal Investigator
  - Vandœuvre-lès-Nancy, France, 54519
    - Withdrawn
    - Institut de Cancerologie de Lorraine
  - Vannes, France, 56000
    - Recruiting
    - Centre d'oncologie Saint-Yves
    - Contact:
      
      Principal Investigator
  - Villeurbanne, France, 69100
    - Recruiting
    - Medipole Hopital Mutualiste
    - Contact:
      
      Principal Investigator
Italy
- - Alessandria, Italy, 15121
    - Recruiting
    - Azienda Ospedaliera di Alessandria
    - Contact:
      
      Principal Investigator
  - Chieti, Italy, 66100
    - Recruiting
    - Ospedale SS Annunziata
    - Contact:
      
      Principal Investigator
  - Città di Castello, Italy, 06012
    - Recruiting
    - Ospedale Citta' di Castello USL Umbria 1
    - Contact:
      
      Principal Investigator
  - Empoli, Italy, 50053
    - Recruiting
    - Ospedale San Giuseppe - Azienda USL Toscana Centro
    - Contact:
      
      Principal Investigator
  - Lecce, Italy, 42100
    - Withdrawn
    - ASL Lecce - Ospedale "Vito Fazzi"
  - Lecco, Italy, 23900
    - Recruiting
    - ASST Lecco - PO "Alessandro Manzoni"
    - Contact:
      
      Principal Investigator
  - Legnago, Italy, 37045
    - Recruiting
    - AULSS 9 Scaligera - Ospedale Mater Salutis
    - Contact:
      
      Principal Investigator
  - Legnano, Italy, 90146
    - Recruiting
    - ASST Ovest Milanese - Ospedale di Legnano
    - Contact:
      
      Principal Investigator
  - Macerata, Italy, 62100
    - Recruiting
    - Ospedale Generale Provinciale di Macerata
    - Contact:
      
      Principal Investigator
  - Meldola, Italy, 47014
    - Recruiting
    - Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
    - Contact:
      
      Principal Investigator
  - Modena, Italy, 73100
    - Recruiting
    - AOU di Modena
    - Contact:
      
      Principal Investigator
  - Monza, Italy, 20900
    - Recruiting
    - Fondazione IRCCS San Gerardo dei Tintori
    - Contact:
      
      Principal Investigator
  - Napoli, Italy, 80131
    - Recruiting
    - AOU Federico II
    - Contact:
      
      Principal Investigator
  - Novara, Italy, 28100
    - Recruiting
    - AOU Maggiore della Carità di Novara
    - Contact:
      
      Principal Investigator
  - Padua, Italy, 35128
    - Recruiting
    - IOV - Istituto Oncologico Veneto - IRCCS
    - Contact:
      
      Principal Investigator
  - Palermo, Italy, 41124
    - Recruiting
    - La Maddalena S.p.A.
    - Contact:
      
      Principal Investigator
  - Palermo, Italy, 90124
    - Recruiting
    - ARNAS Ospedale Civico e Benfratelli
    - Contact:
      
      Principal Investigator
  - Pavia, Italy, 27100
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
    - Contact:
      
      Principal Investigator
  - Pisa, Italy, 89133
    - Recruiting
    - AOU Pisana - Stabilimento Santa Chiara
    - Contact:
      
      Principal Investigator
  - Potenza, Italy, 85100
    - Recruiting
    - AO Regionale San Carlo
    - Contact:
      
      Principal Investigator
  - Reggio Calabria, Italy, 20025
    - Recruiting
    - GOM "BMM" - Presidio Ospedaliero Morelli
    - Contact:
      
      Principal Investigator
  - Reggio Emilia, Italy, 31100
    - Recruiting
    - Azienda USL IRCCS di Reggio Emilia
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00157
    - Recruiting
    - ASL RM 2 Ospedale Pertini
    - Contact:
      
      Principal Investigator
  - Roma, Italy, 00184
    - Recruiting
    - AO San Giovanni Addolorata
    - Contact:
      
      Principal Investigator
  - Salerno, Italy, 84135
    - Recruiting
    - AOU "San Giovanni di Dio e Ruggi d'Aragona"
    - Contact:
      
      Principal Investigator
  - San Giovanni Rotondo, Italy, 71013
    - Recruiting
    - IRCCS Ospedale Casa Sollievo della Sofferenza
    - Contact:
      
      Principal Investigator
  - Sassari, Italy, 56126
    - Recruiting
    - AOU Sassari - Ospedale Civile SS. Annunziata
    - Contact:
      
      Principal Investigator
  - Taormina, Italy, 98039
    - Recruiting
    - Ospedale San Vincenzo
    - Contact:
      
      Principal Investigator
  - Torino, Italy, 10128
    - Recruiting
    - AO Ordine Mauriziano
    - Contact:
      
      Principal Investigator
  - Torino, Italy, 10126
    - Recruiting
    - AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
    - Contact:
      
      Principal Investigator
  - Treviso, Italy, 28100
    - Recruiting
    - AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
    - Contact:
      
      Principal Investigator
  - Udine, Italy, 33100
    - Recruiting
    - ASUFC Udine - Santa Maria della Misericordia
    - Contact:
      
      Principal Investigator
  - Varese, Italy, 22100
    - Recruiting
    - ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
    - Contact:
      
      Principal Investigator
Norway
- - Bodø, Norway, 8005
    - Recruiting
    - Nordlandssjukhuset Bodø
    - Contact:
      
      Principal Investigator
  - Drammen, Norway, 3004
    - Recruiting
    - Drammen Sykehus
    - Contact:
      
      Principal Investigator
  - Kristiansand, Norway, 4615
    - Recruiting
    - Sørlandet sykehus / Kristiansand Hospital
    - Contact:
      
      Principal Investigator
  - Skien, Norway, 3710
    - Recruiting
    - Sykehuset Telemark
    - Contact:
      
      Principal Investigator
  - Tromsø, Norway, 9019
    - Recruiting
    - Universitetssjukhuset Nord-Norge
    - Contact:
      
      Principal Investigator
Portugal
- - Alcabideche, Lisboa, Portugal, 2755-009
    - Not yet recruiting
    - Hospital de Cascais
    - Contact:
      
      Principal Investigator
  - Amadora, Lisboa, Portugal, 2720-276
    - Not yet recruiting
    - ULS Amadora Sintra
    - Contact:
      
      Principal Investigator
  - Braga, Portugal, 4710-243
    - Not yet recruiting
    - ULS Braga
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1500-650
    - Not yet recruiting
    - Hospital Da Luz Lisboa
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - ULS Santa Maria
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1023-099
    - Not yet recruiting
    - Ipo Lisboa
    - Contact:
      
      Principal Investigator
  - Lisbon, Portugal, 1400-038
    - Withdrawn
    - Dra. Berta Sousa
  - Loures, Portugal, 2674-514
    - Recruiting
    - ULS Loures-Odivelas - Hospital Beatriz Ângelo
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4099-001
    - Not yet recruiting
    - ULS Santo António
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4200-162
    - Not yet recruiting
    - Instituto Português de Oncologia do Porto Francisco Gentil
    - Contact:
      
      Principal Investigator
  - Porto, Portugal, 4464-513
    - Not yet recruiting
    - ULS Matosinhos
    - Contact:
      
      Principal Investigator
  - Vila Real, Portugal, 5000-508
    - Not yet recruiting
    - ULS Trás-os-Montes e Alto Douro
    - Contact:
      
      Principal Investigator
Spain
- - Albacete, Spain, 02006
    - Recruiting
    - Hospital Clinico Universitario de Albacete
    - Contact:
      
      Principal Investigator
  - Alzira, Spain, 46600
    - Recruiting
    - Hospital Universitario de La Ribera
    - Contact:
      
      Principal Investigator
  - Barakaldo, Spain, 48903
    - Recruiting
    - Hospital Universitario de Cruces
    - Contact:
      
      Principal Investigator
  - Barcelona, Spain, 08026
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
    - Contact:
      
      Principal Investigator
  - Bilbao, Spain, 48013
    - Recruiting
    - Hospital Universitario de Basurto
    - Contact:
      
      Principal Investigator
  - Cadiz, Spain, 11510
    - Recruiting
    - Hospital Universitario de Puerto Real
    - Contact:
      
      Principal Investigator
  - Cáceres, Spain, 10003
    - Recruiting
    - Hospital Universitario San Pedro de Alcantara
    - Contact:
      
      Principal Investigator
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia
    - Contact:
      
      Principal Investigator
  - Elche, Spain, 03203
    - Recruiting
    - Hospital General Universitario de Elche
    - Contact:
      
      Principal Investigator
  - Galdakao, Spain, 48960
    - Recruiting
    - Hospital de Galdakao
    - Contact:
      
      Principal Investigator
  - Granada, Spain, 18016
    - Recruiting
    - Hospital Clinico Universitario de Granada (PTS)
    - Contact:
      
      Principal Investigator
  - Jaén, Spain, 23007
    - Recruiting
    - Hospital Universitario Médico-Quirúrgico de Jaén
    - Contact:
      
      Principal Investigator
  - León, Spain, 24008
    - Recruiting
    - Complejo Asistencial Universitario de Leon
    - Contact:
      
      Principal Investigator
  - Logroño, Spain, 26006
    - Withdrawn
    - Hospital Universitario San Pedro de Logroño
  - Lugo, Spain, 270003
    - Recruiting
    - Hospital Universitario Lucus Augusti
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramon y Cajal
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28006
    - Recruiting
    - Hospital Universitario La Princesa
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28905
    - Recruiting
    - Hospital de Getafe
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Clinico Universitario San Carlos
    - Contact:
      
      Principal Investigator
  - Madrid, Spain, 28033
    - Recruiting
    - Hospital MD Anderson Cancer Center
    - Contact:
      
      Principal Investigator
  - Murcia, Spain, 30120
    - Recruiting
    - Hospital Virgen Arrixaca de Murcia
    - Contact:
      
      Principal Investigator
  - Oviedo, Spain, 330011
    - Recruiting
    - Hospital Universitario Central de Asturias
    - Contact:
      
      Principal Investigator
  - Palencia, Spain, 34005
    - Recruiting
    - Complejo Asistencial Universitario de Palencia
    - Contact:
      
      Principal Investigator
  - Palma, Spain, 07198
    - Recruiting
    - Hospital Son Llàtzer
    - Contact:
      
      Principal Investigator
  - Palma de Mallorca, Spain, 07210
    - Recruiting
    - Hospital Son Espases
    - Contact:
      
      Principal Investigator
  - Pontevedra, Spain, 36001
    - Recruiting
    - Hospital de Pontevedra
    - Contact:
      
      Principal Investigator
  - Reus, Spain, 43204
    - Recruiting
    - Hospital San Joan de Reus
    - Contact:
      
      Principal Investigator
  - Sabadell, Spain, 08208
    - Recruiting
    - Hospital Universitari Parc Tauli
    - Contact:
      
      Principal Investigator
  - Salamanca, Spain, 37007
    - Recruiting
    - Complejo Asistencial Universitario de Salamanca
    - Contact:
      
      Principal Investigator
  - San Cristóbal de La Laguna, Spain, 38320
    - Recruiting
    - Hospital Universitario de Canarias
    - Contact:
      
      Principal Investigator
  - Sant Cugat del Vallès, Spain, 08195
    - Recruiting
    - Hospital General de Catalunya
    - Contact:
      
      Principal Investigator
  - Santander, Spain, 39008
    - Recruiting
    - Hospital Universitario Marques de Valdecilla
    - Contact:
      
      Principal Investigator
  - Valencia, Spain, 46014
    - Recruiting
    - Hospital Universitario General de Valencia
    - Contact:
      
      Principal Investigator
  - Valladolid, Spain, 47012
    - Recruiting
    - Hospital Universitario Río Hortega
    - Contact:
      
      Principal Investigator
  - Valladolid, Spain, 47003
    - Recruiting
    - Hospital Clínico de Valladolid
    - Contact:
      
      Principal Investigator
  - Vigo Pontevedra, Spain, 36312
    - Recruiting
    - Complejo Hospitalario Universitario de Vigo
    - Contact:
      
      Principal Investigator
Sweden
- - Eskilstuna, Sweden, 63188
    - Recruiting
    - Onkologikliniken Mälarsjukhuset
    - Contact:
      
      Principal Investigator
  - Gävle, Sweden, 80324
    - Recruiting
    - Gävle hospital
    - Contact:
      
      Principal Investigator
  - Jönköping, Sweden, 55185
    - Recruiting
    - Ryhov County Hospital
    - Contact:
      
      Principal Investigator
  - Stockholm, Sweden, 11912
    - Recruiting
    - Capio St Görans Sjukhus
    - Contact:
      
      Principal Investigator
  - Stockholm, Sweden, 17176
    - Recruiting
    - Bröstcentrum, Karolinska Universitetssjukhuset Solna
    - Contact:
      
      Principal Investigator
  - Sundsvall, Sweden, 85643
    - Withdrawn
    - Onkologkliniken Sundsvalls Sjukhus
  - Umeå, Sweden, 901 85
    - Recruiting
    - Cancercentrum, Norrlands Universitetssjukhus
    - Contact:
      
      Principal Investigator
  - Västerås, Sweden, 72335
    - Recruiting
    - Department of Oncology, Västerås
    - Contact:
      
      Principal Investigator
  - Örebro, Sweden, 70185
    - Recruiting
    - Department of Oncology, Örebro University Hospital
    - Contact:
      
      Principal Investigator
Switzerland
- - Baden, Switzerland, 5404
    - Active, not recruiting
    - Kantonsspital Baden
  - Frauenfeld, Switzerland, 8500
    - Terminated
    - Spital Thurgau AG - Kantonsspital Frauenfeld
  - Fribourg, Switzerland, 1701
    - Active, not recruiting
    - Centre du Sein Fribourg
  - Geneva, Switzerland, 1206
    - Active, not recruiting
    - Clinique Generale-Beaulieu / Clinique de Genolier
  - La Chaux-de-Fonds, Switzerland, 2300
    - Active, not recruiting
    - Réseau Hospitalier Neuchâtelois (RHNe)
  - Lausanne, Switzerland, 1003
    - Active, not recruiting
    - Réseau du Sein Lausanne
  - Lausanne, Switzerland, 1011
    - Active, not recruiting
    - CHUV
  - Liestal, Switzerland, 4410
    - Active, not recruiting
    - Kantonsspital Baselland
  - Sankt Gallen, Switzerland, 9007
    - Not yet recruiting
    - Kantonsspital St.Gallen
    - Contact:
      
      Principal Investigator
  - Sion, Switzerland, 1951
    - Active, not recruiting
    - Hôpital du Valais Sion
  - Zurich, Switzerland, 8091
    - Active, not recruiting
    - Universitatsspital Zurich
  - Zurich, Switzerland, 8005
    - Active, not recruiting
    - ZIO AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
Documented HER2-low status (IHC1+, IHC2+/ISH-)
Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
Written and signed Informed Consent to participate in the study

Exclusion Criteria:

Pregnancy or breastfeeding
Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trastuzumab deruxtecan (T-DXd) Participants with HER2-low expressing unresectable and/or metastatic breast cancer who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional chemotherapy. The participants on conventional chemotherapy will be analyzed exploratory only.	Drug: Trastuzumab deruxtecan This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC. Other Names: T-DXd

Group / Cohort

Intervention / Treatment

Trastuzumab deruxtecan (T-DXd)

Participants with HER2-low expressing unresectable and/or metastatic breast cancer who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional chemotherapy. The participants on conventional chemotherapy will be analyzed exploratory only.

Drug: Trastuzumab deruxtecan

This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice.

Trastuzumab (T-DXd) to be administered according to the SmPC.

Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.

Other Names:

T-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Time Frame: Baseline up to 31 months	Baseline up to 31 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Time Frame: Baseline up to 31 months		Baseline up to 31 months
Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) Time Frame: Baseline up to 31 months		Baseline up to 31 months
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) Time Frame: Baseline up to 31 months		Baseline up to 31 months
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Time Frame: Baseline up to 31 months		Baseline up to 31 months
Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Time Frame: Baseline up to 31 months	The PGI-TT is designed to assess the treatment tolerability of the medicine. Participants will rate the bother associated with any treatment-related symptoms based on a 5-point scale ranging from 1 (not at all) to 5 (very much). Higher scores indicate a worse outcome.	Baseline up to 31 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Time Frame: Baseline up to 31 months	The EORTC QLQ-C30 questionnaire is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).	Baseline up to 31 months
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary Time Frame: Baseline up to 31 months		Baseline up to 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

Study Director: Global Team Leader, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Guarneri V, Passos Coelho JL, Duhoux FP, Egle D, Garcia-Saenz JA, Penault-Llorca F, Selander K, Wildiers H, Zaman K, Laeis P, Lucerna M, Pierga JY. Study design for DESTINY-Breast Respond HER2-low Europe: T-DXd in patients with HER2-low advanced breast cancer. Future Oncol. 2024;20(18):1237-1250. doi: 10.2217/fon-2024-0015. Epub 2024 Apr 9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DS8201-0005-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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