DESTINY Breast Respond HER2-(Ultra)Low Europe

A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)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.

Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new patient population will be enrolled, comprising adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; Unresectable Breast Cancer; HER2-low Expressing Breast Cancer; HER2-(Ultra)Low Expressing Breast Cancer
• Intervention / Treatment: Drug: Trastuzumab deruxtecan

Detailed Description

This non-interventional study will investigate the effectiveness of T-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 and HER2-(ultra)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. For Study Group 2, only baseline data will be collected for patients treated with conventional chemotherapy.

• Study Type: Observational
• Enrollment (Estimated): 2295

Contacts and Locations

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

Study Locations

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    • Withdrawn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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study Group 1 will include 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 Group 2 will include adult patients with unresectable or metastatic HR +, HER2-low and HER2- ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment and have not received prior chemotherapy for advanced metastatic breast cancer.

Description

Inclusion Criteria:

Study Group 1 and Study Group 2

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

Study Group 1

• 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

Study Group 2:

• Documented HR+ status
• Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0 with membrane staining [IHC > 0 to <1+]) status
• Patients who have received at least one endocrine therapy in the metastatic setting
• Patients who have NOT received prior chemotherapy in the metastatic setting

Exclusion Criteria:

Study Group 1 and Study Group 2

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group 1; Adult participants with 2L+ HER2-low expressing unresectable and/or metastatic breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. In addition, patients with HER2-low breast cancer treated with conventional chemotherapy will be enrolled. The participants on conventional chemotherapy will be analyzed as 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
Study Group 2; Adult participants in the first-line setting with hormone receptor (HR) positive, HER2-low or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment and have not received prior chemotherapy for advanced metastatic breast cancer.	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 Unresectable and/or Metastatic Breast Cancer	Baseline up to approximately 37 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer		Baseline up to approximately 37 months
Number of Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)		Baseline up to approximately 37 months
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)		Baseline up to approximately 37 months
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer		Baseline up to approximately 37 months
Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With Unresectable and/or Metastatic Breast Cancer	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 approximately 37 months
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With Unresectable and/or Metastatic Breast Cancer	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 approximately 37 months
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary		Baseline up to approximately 37 months

Collaborators and Investigators

• 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

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

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

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): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer; Trastuzumab Deruxtecan; Unresectable Breast Cancer; HER2-low Expressing Breast Cancer; Enhertu®; HER2-(ultra)low Expressing Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Immunoconjugates; trastuzumab deruxtecan
• Other Study ID Numbers: DS8201-0005-NIS-MA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No