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)
1 other identifier
observational
2,295
10 countries
211
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
October 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
June 29, 2026
June 1, 2026
7.2 years
July 6, 2023
June 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer
Baseline up to approximately 37 months
Secondary Outcomes (7)
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
Baseline up to approximately 37 months
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (211)
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020, Austria
LKH Hochsteiermark-Leoben
Leoben, 8700, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010, Austria
Interne II, LKH Feldkirch
Rankweil, 6830, Austria
KH der Barmherzigen Brüder Salzburg
Salzburg, 5010, Austria
Uniklinikum Salzburg
Salzburg, 5020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Krankenhaus Hietzing
Vienna, 1130, Austria
Salzkammergut Klinikum Vöcklabruck
Vöcklabruck, 4840, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700, Austria
ASZ Aalst
Aalst, 9300, Belgium
Chirec Delta Hospital
Auderghem, 1160, Belgium
Imeldaziekenhuis Bonheiden
Bonheiden, 2820, Belgium
AZ Klina
Brasschaat, 2930, Belgium
AZ Sint-Jan Brugge av
Bruges, 8000, Belgium
CHU Brugmann
Brussels, 1020, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Chu Helora- Hôpital de La Louvière- site Jolimont
Haine-Saint-Paul, 7100, Belgium
Jessa Ziekenhuis
Hasselt, 3500, Belgium
CHU Tivoli
La Louvière, 7100, Belgium
CHC MontLegia
Liège, 4000, Belgium
Hôpital de la Citadelle
Liège, 4000, Belgium
CHU UCL Namur/Site Sainte Elisabeth
Namur, B5000, Belgium
Clinique Saint Pierre Ottignies
Ottignies, 1340, Belgium
VITAZ
Sint-Niklaas, 9100, Belgium
CHR Verviers East Belgium
Verviers, 4800, Belgium
Aalborg Universitetshospital, Syd
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Onkologisk og Palliativ afdeling, Nordsjællands Hospital
Hillerød, 3400, Denmark
Naestved Hospital
Næstved, 4700, Denmark
Sygehus Sønderjylland, Sønderborg
Sønderborg, 6400, Denmark
CHU Amiens Picardie
Amiens, 80000, France
Clinique de l'Europe
Amiens, 80090, France
Hôpital Privé d'Antony
Antony, 92160, France
Hôpital Privé les Bonnettes
Arras, 62000, France
Institut du Cancer Avignon Provence
Avignon, 84918, France
CH Cote Basque
Bayonne, 64100, France
Clinique Belharra
Bayonne, 64100, France
Chu Jean Minjoz Besancon
Besançon, 25000, France
Clinique Tivoli-Ducos
Bordeaux, 33000, France
Centre hospitalier Fleyriat
Bourg-en-Bresse, 01012, France
Centre Francois Baclesse
Caen, 14000, France
Centre Hospitalier William Morey
Chalon-sur-Saône, 71321, France
CH Metropole Savoie
Chambéry, 73000, France
Pole Sante Leonard De Vinci
Chambray-lès-Tours, 37170, France
CH Cholet
Cholet, 49300, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Polyclinique St Côme
Compiègne, 60200, France
Hôpital Henri Mondor
Créteil, 94000, France
Centre Léonard de Vinci
Dechy, 59187, France
Centre Georges Francois Leclerc
Dijon, 21000, France
CHU Martinique
Fort de France Cedex, 97261, France
CHI Frejus Saint Raphael
Fréjus, 83600, France
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
Grenoble, 38000, France
Polyclinique De Blois
La Chaussée-Saint-Victor, 41260, France
La Tronche - CHU Grenoble
La Tronche, 38700, France
Centre de cancerologie de la Sarthe
Le Mans, 72100, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000, France
Hôpital Franco-Britannique Cognac Jay
Levallois-Perret, 92300, France
Centre Oscar Lambret
Lille, 59000, France
CHU Lille
Lille, 59000, France
Hôpital Prive Le Bois
Lille, 59000, France
CHU de Limoges
Limoges, 87042, France
Hospices Civils De Lyon
Lyon, 69002, France
Hôpital Jean Mermoz
Lyon, 69008, France
Hôpital-Clinique Claude Bernard
Metz, 57070, France
GH Havre
Montivilliers, 76920, France
Clinique Clementville
Montpellier, 34070, France
Groupe Hospitalier privé Ambroise Pare Hartmann
Neuilly-sur-Seine, 92200, France
Hopital Americain de Paris
Neuilly-sur-Seine, 92200, France
Centre Antoine Lacassagne
Nice, 06100, France
Centre Hospitalier de Niort
Niort, 79000, France
Centre Médical ONCOGARD
Nîmes, 30029, France
Institut Curie
Paris, 75005, France
Groupement Hospitalier Diaconesses Croix Saint Simon
Paris, 75012, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hôpital Saint Joseph
Paris, 75103, France
Centre Hospitalier de Pau
Pau, 64000, France
CHU Poitiers
Poitiers, 86000, France
Institut Godinot
Reims, 51100, France
Polyclinique Courlancy
Reims, 51100, France
Centre Eugene Marquis
Rennes, 35042, France
Clinique Saint Hilaire
Rouen, 76000, France
Clinique Mathilde
Rouen, 76100, France
Saint Cloud -Rene Huguenin Institut Curie
Saint-Cloud, 92210, France
CHU Réunion Site Sud
Saint-Paul, 97460, France
Institut De Cancerologie Paris Nord
Sarcelles, 95200, France
Centre Hospitalier de Sens
Sens Cédex, 89108, France
Hôpital Foch
Suresnes, 92150, France
CHR Metz Thionville
Thionville, 57100, France
HIA Sainte-Anne
Toulon, 83000, France
Centre Hospitalier de Troyes
Troyes, 10000, France
Hopital Prive Drome Ardeche
Valence, 26000, France
Nouvelle Clinique Des Dentellières
Valenciennes, 59300, France
Institut De Cancerologie De Lorraine
Vandœuvre-lès-Nancy, 54519, France
Centre d'oncologie Saint-Yves
Vannes, 56000, France
Médipôle Hôpital Mutualiste
Villeurbanne, 69100, France
Azienda Ospedaliera di Alessandria
Alessandria, 15121, Italy
Ospedale SS Annunziata
Chieti, 66100, Italy
Ospedale Citta' di Castello USL Umbria 1
Città di Castello, 06012, Italy
Ospedale San Giuseppe - Azienda USL Toscana Centro
Empoli, 50053, Italy
ASL Lecce - Ospedale "Vito Fazzi"
Lecce, 42100, Italy
ASST Lecco - PO "Alessandro Manzoni"
Lecco, 23900, Italy
AULSS 9 Scaligera - Ospedale Mater Salutis
Legnago, 37045, Italy
ASST Ovest Milanese - Ospedale di Legnano
Legnano, 90146, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola, 47014, Italy
AOU di Modena
Modena, 73100, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900, Italy
AOU Federico II
Naples, 80131, Italy
AOU Maggiore della Carità di Novara
Novara, 28100, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, 35128, Italy
La Maddalena S.p.A.
Palermo, 41124, Italy
ARNAS Ospedale Civico e Benfratelli
Palermo, 90124, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
AOU Pisana - Stabilimento Santa Chiara
Pisa, 89133, Italy
AO Regionale San Carlo
Potenza, 85100, Italy
Ospedale Generale Provinciale di Macerata
Province of Macerata, 62100, Italy
GOM "BMM" - Presidio Ospedaliero Morelli
Reggio Calabria, 20025, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, 31100, Italy
ASL RM 2 Ospedale Pertini
Roma, 00157, Italy
AO San Giovanni Addolorata
Roma, 00184, Italy
AOU "San Giovanni di Dio e Ruggi d'Aragona"
Salerno, 84135, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
AOU Sassari - Ospedale Civile SS. Annunziata
Sassari, 56126, Italy
Ospedale San Vincenzo
Taormina, 98039, Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
Treviso, 28100, Italy
ASUFC Udine - Santa Maria della Misericordia
Udine, 33100, Italy
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
Varese, 22100, Italy
Nordlandssjukhuset Bodø
Bodø, 8005, Norway
Drammen Sykehus
Drammen, 3004, Norway
Sørlandet sykehus / Kristiansand Hospital
Kristiansand, 4615, Norway
Sykehuset Telemark
Skien, 3710, Norway
Universitetssjukhuset Nord-Norge
Tromsø, 9019, Norway
Hospital de Cascais
Alcabideche, Lisboa, 2755-009, Portugal
ULS Amadora Sintra
Amadora, Lisboa, 2720-276, Portugal
ULS Braga
Braga, 4710-243, Portugal
IPO Lisboa
Lisbon, 1023-099, Portugal
Dra. Berta Sousa
Lisbon, 1400-038, Portugal
Hospital da Luz Lisboa
Lisbon, 1500-650, Portugal
ULS Santa Maria
Lisbon, 1649-035, Portugal
ULS Loures-Odivelas - Hospital Beatriz Ângelo
Loures, 2674-514, Portugal
ULS Santo António
Porto, 4099-001, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, 4200-162, Portugal
ULS Matosinhos
Porto, 4464-513, Portugal
ULS Trás-os-Montes e Alto Douro
Vila Real, 5000-508, Portugal
Hospital Clinico Universitario de Albacete
Albacete, 02006, Spain
Hospital Universitario de La Ribera
Alzira, 46600, Spain
Hospital Universitario de Cruces
Barakaldo, 48903, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Hospital Universitario de Puerto Real
Cadiz, 11510, Spain
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital de Galdakao
Galdakao, 48960, Spain
Hospital Clinico Universitario de Granada (PTS)
Granada, 18016, Spain
Hospital Universitario Médico-Quirúrgico de Jaén
Jaén, 23007, Spain
Complejo Asistencial Universitario de León
León, 24008, Spain
Hospital Universitario San Pedro de Logroño
Logroño, 26006, Spain
Hospital Universitario Lucus Augusti
Lugo, 270003, Spain
Hospital Universitario la Princesa
Madrid, 28006, Spain
Hospital MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital de Getafe
Madrid, 28905, Spain
Hospital Virgen Arrixaca de Murcia
Murcia, 30120, Spain
Hospital Universitario Central de Asturias
Oviedo, 330011, Spain
Complejo Asistencial Universitario de Palencia
Palencia, 34005, Spain
Hospital Son Llatzer
Palma, 07198, Spain
Hospital Son Espases
Palma de Mallorca, 07210, Spain
Hospital de Pontevedra
Pontevedra, 36001, Spain
Hospital San Joan de Reus
Reus, 43204, Spain
Hospital Universitari Parc Taulí
Sabadell, 08208, Spain
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, 08195, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario General de Valencia
Valencia, 46014, Spain
Hospital Clínico de Valladolid
Valladolid, 47003, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
Complejo Hospitalario Universitario De Vigo
Vigo Pontevedra, 36312, Spain
Onkologikliniken Mälarsjukhuset
Eskilstuna, 63188, Sweden
Gävle Hospital
Gävle, 80324, Sweden
Ryhov County Hospital
Jönköping, 55185, Sweden
Department of Oncology, Örebro University Hospital
Örebro, 70185, Sweden
Capio St Görans sjukhus
Stockholm, 11912, Sweden
Bröstcentrum, Karolinska Universitetssjukhuset Solna
Stockholm, 17176, Sweden
Onkologkliniken Sundsvalls Sjukhus
Sundsvall, 85643, Sweden
Cancercentrum, Norrlands Universitetssjukhus
Umeå, 901 85, Sweden
Department of Oncology, Västerås
Västerås, 72335, Sweden
Kantonsspital Baden
Baden, 5404, Switzerland
Spital Thurgau AG - Kantonsspital Frauenfeld
Frauenfeld, 8500, Switzerland
Centre du sein Fribourg
Fribourg, 1701, Switzerland
Clinique Generale-Beaulieu / Clinique de Genolier
Geneva, 1206, Switzerland
Réseau Hospitalier Neuchâtelois (RHNe)
La Chaux-de-Fonds, 2300, Switzerland
Réseau du Sein Lausanne
Lausanne, 1003, Switzerland
CHUV
Lausanne, 1011, Switzerland
Kantonsspital Baselland
Liestal, 4410, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
Hôpital du Valais Sion
Sion, 1951, Switzerland
ZIO AG
Zurich, 8005, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 38592002DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Team Leader
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 14, 2023
Study Start
October 24, 2023
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
June 29, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share