Unresectable Breast CancerNCT05945732

DESTINY Breast Respond HER2-(Ultra)Low Europe

An observational study of Unresectable Breast Cancer and Metastatic Breast Cancer, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 216 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer
What is being tested?: Trastuzumab deruxtecan
How many people: 2,295 participants
Where: 216 sitesin 10 countries
Study dates: 24 Oct 2023to 31 Dec 2030
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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-)

Show all 13Show fewer

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

Who cannot join

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.

Trial locations and contacts

216 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Contact for Clinical Trial Information contact

908-992-6400

CTRinfo@dsi.com

Country

City, postcode or hospital

Sites recruiting now only

216 sites in 10 countries

France66 sites

CHU Amiens Picardie
Amiens, 80000
Active, not recruiting
Clinique de l'Europe
Amiens, 80090
Active, not recruiting
Hôpital Privé d'Antony
Antony, 92160
Withdrawn
Hôpital Privé les Bonnettes
Arras, 62000
Active, not recruiting
Institut du Cancer Avignon Provence
Avignon, 84918
Active, not recruiting
CH Cote Basque
Bayonne, 64100
Active, not recruiting
Clinique Belharra
Bayonne, 64100
Withdrawn
Chu Jean Minjoz Besancon
Besançon, 25000
Active, not recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Active, not recruiting
Centre hospitalier Fleyriat
Bourg-en-Bresse, 01012
Active, not recruiting
Centre Francois Baclesse
Caen, 14000
Active, not recruiting
Centre Hospitalier William Morey
Chalon-sur-Saône, 71321
Active, not recruiting
CH Metropole Savoie
Chambéry, 73000
Active, not recruiting
Pole Sante Leonard De Vinci
Chambray-lès-Tours, 37170
Active, not recruiting
CH Cholet
Cholet, 49300
Active, not recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Active, not recruiting
Polyclinique St Côme
Compiègne, 60200
Active, not recruiting
Hôpital Henri Mondor
Créteil, 94000
Active, not recruiting
Centre Léonard de Vinci
Dechy, 59187
Active, not recruiting
Centre Georges Francois Leclerc
Dijon, 21000
Active, not recruiting
CHU Martinique
Fort de France Cedex, 97261
Active, not recruiting
CHI Frejus Saint Raphael
Fréjus, 83600
Active, not recruiting
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
Grenoble, 38000
Active, not recruiting
Polyclinique De Blois
La Chaussée-Saint-Victor, 41260
Withdrawn
La Tronche - CHU Grenoble
La Tronche, 38700
Active, not recruiting
Centre de cancerologie de la Sarthe
Le Mans, 72100
Active, not recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Active, not recruiting
Hôpital Franco-Britannique Cognac Jay
Levallois-Perret, 92300
Active, not recruiting
Centre Oscar Lambret
Lille, 59000
Active, not recruiting
CHU Lille
Lille, 59000
Active, not recruiting
Hôpital Prive Le Bois
Lille, 59000
Active, not recruiting
CHU de Limoges
Limoges, 87042
Active, not recruiting
Hospices Civils De Lyon
Lyon, 69002
Active, not recruiting
Hôpital Jean Mermoz
Lyon, 69008
Active, not recruiting
Hôpital-Clinique Claude Bernard
Metz, 57070
Withdrawn
GH Havre
Montivilliers, 76920
Active, not recruiting
Clinique Clementville
Montpellier, 34070
Active, not recruiting
Groupe Hospitalier privé Ambroise Pare Hartmann
Neuilly-sur-Seine, 92200
Active, not recruiting
Hopital Americain de Paris
Neuilly-sur-Seine, 92200
Active, not recruiting
Centre Antoine Lacassagne
Nice, 06100
Active, not recruiting
Centre Médical ONCOGARD
Nîmes, 30029
Active, not recruiting
Centre Hospitalier de Niort
Niort, 79000
Active, not recruiting
Institut Curie
Paris, 75005
Active, not recruiting
Groupement Hospitalier Diaconesses Croix Saint Simon
Paris, 75012
Active, not recruiting
Hopital Europeen Georges Pompidou
Paris, 75015
Active, not recruiting
Hôpital Saint Joseph
Paris, 75103
Active, not recruiting
Centre Hospitalier de Pau
Pau, 64000
Active, not recruiting
CHU Poitiers
Poitiers, 86000
Active, not recruiting
Institut Godinot
Reims, 51100
Active, not recruiting
Polyclinique Courlancy
Reims, 51100
Withdrawn
Centre Eugene Marquis
Rennes, 35042
Active, not recruiting
Clinique Saint Hilaire
Rouen, 76000
Withdrawn
Clinique Mathilde
Rouen, 76100
Active, not recruiting
Saint Cloud -Rene Huguenin Institut Curie
Saint-Cloud, 92210
Withdrawn
CHU Réunion Site Sud
Saint-Paul, 97460
Active, not recruiting
Institut De Cancerologie Paris Nord
Sarcelles, 95200
Active, not recruiting
Centre Hospitalier de Sens
Sens Cédex, 89108
Active, not recruiting
Hôpital Foch
Suresnes, 92150
Active, not recruiting
CHR Metz Thionville
Thionville, 57100
Active, not recruiting
HIA Sainte-Anne
Toulon, 83000
Active, not recruiting
Centre Hospitalier de Troyes
Troyes, 10000
Withdrawn
Hopital Prive Drome Ardeche
Valence, 26000
Active, not recruiting
Nouvelle Clinique Des Dentellières
Valenciennes, 59300
Active, not recruiting
Institut De Cancerologie De Lorraine
Vandœuvre-lès-Nancy, 54519
Withdrawn
Centre d'oncologie Saint-Yves
Vannes, 56000
Active, not recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
Active, not recruiting

Other trials in France

Spain42 sites, 5 recruiting

Hospital Clinico Universitario de Albacete
Albacete, 02006
Active, not recruiting
Hospital General Universitario de Alicante
Alicante, 03010
Principal Investigator
Not yet recruiting
Hospital Universitario de La Ribera
Alzira, 46600
Active, not recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
Terminated
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Active, not recruiting
Hosp. Univ. de Bellvitge - Ico Hospitalet - Duran I Reynals
Barcelona, 08908
Principal Investigator
Not yet recruiting
Hospital Universitario de Basurto
Bilbao, 48013
Active, not recruiting
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003
Active, not recruiting
Hospital Universitario de Puerto Real
Cadiz, 11510
Active, not recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Active, not recruiting
Hospital General Universitario de Elche
Elche, 03203
Active, not recruiting
Hospital de Galdakao
Galdakao, 48960
Active, not recruiting
Hospital Clinico Universitario de Granada (PTS)
Granada, 18016
Active, not recruiting
Hospital Universitario Médico-Quirúrgico de Jaén
Jaén, 23007
Active, not recruiting
Complejo Asistencial Universitario de León
León, 24008
Terminated
Hospital Universitario San Pedro de Logroño
Logroño, 26006
Withdrawn
Hospital Universitario Lucus Augusti
Lugo, 270003
Active, not recruiting
Hospital Universitario la Princesa
Madrid, 28006
Active, not recruiting
Hospital MD Anderson Cancer Center
Madrid, 28033
Active, not recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Active, not recruiting
Hospital Clínico Universitario San Carlos
Madrid, 28040
Active, not recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Active, not recruiting
Hospital Universitario La Paz
Madrid, 28046
Principal Investigator
Not yet recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28222
Principal Investigator
Not yet recruiting
Hospital de Getafe
Madrid, 28905
Active, not recruiting
Hospital Virgen Arrixaca de Murcia
Murcia, 30120
Active, not recruiting
Hospital Universitario Central de Asturias
Oviedo, 330011
Active, not recruiting
Complejo Asistencial Universitario de Palencia
Palencia, 34005
Terminated
Hospital Son Llatzer
Palma, 07198
Terminated
Hospital Son Espases
Palma de Mallorca, 07210
Active, not recruiting
Hospital de Pontevedra
Pontevedra, 36001
Active, not recruiting
Hospital San Joan de Reus
Reus, 43204
Active, not recruiting
Hospital Universitari Parc Taulí
Sabadell, 08208
Active, not recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Terminated
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320
Active, not recruiting
Hospital General de Catalunya
Sant Cugat del Vallès, 08195
Active, not recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Active, not recruiting
Hospital Universitario General de Valencia
Valencia, 46014
Active, not recruiting
Hospital Clínico de Valladolid
Valladolid, 47003
Active, not recruiting
Hospital Universitario Rio Hortega
Valladolid, 47012
Active, not recruiting
Complejo Hospitalario Universitario De Vigo
Vigo Pontevedra, 36312
Active, not recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Principal Investigator
Not yet recruiting

Other trials in Spain

Italy33 sites

Azienda Ospedaliera di Alessandria
Alessandria, 15121
Active, not recruiting
Ospedale SS Annunziata
Chieti, 66100
Active, not recruiting
Ospedale Citta' di Castello USL Umbria 1
Città di Castello, 06012
Terminated
Ospedale San Giuseppe - Azienda USL Toscana Centro
Empoli, 50053
Active, not recruiting
ASL Lecce - Ospedale "Vito Fazzi"
Lecce, 42100
Withdrawn
ASST Lecco - PO "Alessandro Manzoni"
Lecco, 23900
Active, not recruiting
AULSS 9 Scaligera - Ospedale Mater Salutis
Legnago, 37045
Active, not recruiting
ASST Ovest Milanese - Ospedale di Legnano
Legnano, 90146
Active, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
Meldola, 47014
Active, not recruiting
AOU di Modena
Modena, 73100
Active, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Active, not recruiting
AOU Federico II
Naples, 80131
Active, not recruiting
AOU Maggiore della Carità di Novara
Novara, 28100
Active, not recruiting
IOV - Istituto Oncologico Veneto - IRCCS
Padova, 35128
Active, not recruiting
La Maddalena S.p.A.
Palermo, 41124
Terminated
ARNAS Ospedale Civico e Benfratelli
Palermo, 90124
Active, not recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Active, not recruiting
AOU Pisana - Stabilimento Santa Chiara
Pisa, 89133
Active, not recruiting
AO Regionale San Carlo
Potenza, 85100
Active, not recruiting
Ospedale Generale Provinciale di Macerata
Province of Macerata, 62100
Active, not recruiting
GOM "BMM" - Presidio Ospedaliero Morelli
Reggio Calabria, 20025
Active, not recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, 31100
Active, not recruiting
ASL RM 2 Ospedale Pertini
Roma, 00157
Active, not recruiting
AO San Giovanni Addolorata
Roma, 00184
Active, not recruiting
AOU "San Giovanni di Dio e Ruggi d'Aragona"
Salerno, 84135
Active, not recruiting
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Active, not recruiting
AOU Sassari - Ospedale Civile SS. Annunziata
Sassari, 56126
Active, not recruiting
Ospedale San Vincenzo
Taormina, 98039
Active, not recruiting
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126
Active, not recruiting
AO Ordine Mauriziano
Torino, 10128
Active, not recruiting
AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
Treviso, 28100
Active, not recruiting
ASUFC Udine - Santa Maria della Misericordia
Udine, 33100
Active, not recruiting
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
Varese, 22100
Active, not recruiting

Other trials in Italy

Belgium16 sites

ASZ Aalst
Aalst, 9300
Active, not recruiting
Chirec Delta Hospital
Auderghem, 1160
Active, not recruiting
Imeldaziekenhuis Bonheiden
Bonheiden, 2820
Active, not recruiting
AZ Klina
Brasschaat, 2930
Active, not recruiting
AZ Sint-Jan Brugge av
Bruges, 8000
Active, not recruiting
CHU Brugmann
Brussels, 1020
Active, not recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Active, not recruiting
Chu Helora- Hôpital de La Louvière- site Jolimont
Haine-Saint-Paul, 7100
Active, not recruiting
Jessa Ziekenhuis
Hasselt, 3500
Active, not recruiting
CHU Tivoli
La Louvière, 7100
Active, not recruiting
CHC MontLegia
Liège, 4000
Active, not recruiting
Hôpital de la Citadelle
Liège, 4000
Active, not recruiting
CHU UCL Namur/Site Sainte Elisabeth
Namur, B5000
Active, not recruiting
Clinique Saint Pierre Ottignies
Ottignies, 1340
Active, not recruiting
VITAZ
Sint-Niklaas, 9100
Active, not recruiting
CHR Verviers East Belgium
Verviers, 4800
Active, not recruiting

Other trials in Belgium

Austria15 sites, 10 recruiting

Medizinische Universität Graz
Graz, 8036
Terminated
Medizinische Universität Graz
Graz, 8036
Principal Investigator
Recruiting
Medizinische Universität Innsbruck
Innsbruck, 6020
Recruiting
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Principal Investigator
Recruiting
LKH Hochsteiermark-Leoben
Leoben, 8700
Withdrawn
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010
Principal Investigator
Recruiting
Interne II, LKH Feldkirch
Rankweil, 6830
Active, not recruiting
KH der Barmherzigen Brüder Salzburg
Salzburg, 5010
Principal Investigator
Recruiting
Uniklinikum Salzburg
Salzburg, 5020
Principal Investigator
Recruiting
Medical University of Vienna
Vienna, 1090
Principal Investigator
Recruiting
Medizinische Universität Wien
Vienna, 1090
Terminated
Krankenhaus Hietzing
Vienna, 1130
Principal Investigator
Recruiting
Salzkammergut Klinikum Vöcklabruck
Vöcklabruck, 4840
Principal Investigator
Recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
Active, not recruiting
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700
Principal Investigator
Recruiting

Other trials in Austria

Portugal12 sites

Hospital de Cascais
Alcabideche, Lisboa, 2755-009
Withdrawn
ULS Amadora Sintra
Amadora, Lisboa, 2720-276
Withdrawn
ULS Braga
Braga, 4710-243
Withdrawn
IPO Lisboa
Lisbon, 1023-099
Withdrawn
Dra. Berta Sousa
Lisbon, 1400-038
Withdrawn
Hospital da Luz Lisboa
Lisbon, 1500-650
Withdrawn
ULS Santa Maria
Lisbon, 1649-035
Withdrawn
ULS Loures-Odivelas - Hospital Beatriz Ângelo
Loures, 2674-514
Withdrawn
ULS Santo António
Porto, 4099-001
Withdrawn
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, 4200-162
Withdrawn
ULS Matosinhos
Porto, 4464-513
Withdrawn
ULS Trás-os-Montes e Alto Douro
Vila Real, 5000-508
Withdrawn

Other trials in Portugal

Switzerland12 sites, 9 recruiting

Kantonsspital Baden
Baden, 5404
Principal Investigator
Recruiting
Spital Thurgau AG - Kantonsspital Frauenfeld
Frauenfeld, 8500
Terminated
Centre du sein Fribourg
Fribourg, 1701
Principal Investigator
Recruiting
Clinique Generale-Beaulieu / Clinique de Genolier
Geneva, 1206
Principal Investigator
Recruiting
Réseau Hospitalier Neuchâtelois (RHNe)
La Chaux-de-Fonds, 2300
Principal Investigator
Recruiting
Réseau du Sein Lausanne
Lausanne, 1003
Principal Investigator
Recruiting
CHUV
Lausanne, 1011
Principal Investigator
Recruiting
Kantonsspital Baselland
Liestal, 4410
Principal Investigator
Recruiting
Kantonsspital St.Gallen
Sankt Gallen, 9007
Principal Investigator
Not yet recruiting
Hôpital du Valais Sion
Sion, 1951
Terminated
ZIO AG
Zurich, 8005
Active, not recruiting
Universitätsspital Zürich
Zurich, 8091
Principal Investigator
Recruiting

Other trials in Switzerland

Sweden9 sites, 5 recruiting

Onkologikliniken Mälarsjukhuset
Eskilstuna, 63188
Principal Investigator
Recruiting
Gävle Hospital
Gävle, 80324
Principal Investigator
Recruiting
Ryhov County Hospital
Jönköping, 55185
Active, not recruiting
Department of Oncology, Örebro University Hospital
Örebro, 70185
Principal Investigator
Recruiting
Capio St Görans sjukhus
Stockholm, 11912
Active, not recruiting
Bröstcentrum, Karolinska Universitetssjukhuset Solna
Stockholm, 17176
Active, not recruiting
Onkologkliniken Sundsvalls Sjukhus
Sundsvall, 85643
Withdrawn
Cancercentrum, Norrlands Universitetssjukhus
Umeå, 901 85
Principal Investigator
Recruiting
Department of Oncology, Västerås
Västerås, 72335
Principal Investigator
Recruiting

Other trials in Sweden

Denmark6 sites

Aalborg Universitetshospital, Syd
Aalborg, 9000
Terminated
Aarhus University Hospital
Aarhus N, 8200
Active, not recruiting
Herlev Hospital
Herlev, 2730
Active, not recruiting
Onkologisk og Palliativ afdeling, Nordsjællands Hospital
Hillerød, 3400
Active, not recruiting
Naestved Hospital
Næstved, 4700
Active, not recruiting
Sygehus Sønderjylland, Sønderborg
Sønderborg, 6400
Terminated

Other trials in Denmark

Norway5 sites, 3 recruiting

Nordlandssjukhuset Bodø
Bodø, 8005
Principal Investigator
Recruiting
Drammen Sykehus
Drammen, 3004
Principal Investigator
Recruiting
Sørlandet sykehus / Kristiansand Hospital
Kristiansand, 4615
Active, not recruiting
Sykehuset Telemark
Skien, 3710
Principal Investigator
Recruiting
Universitetssjukhuset Nord-Norge
Tromsø, 9019
Active, not recruiting

Other trials in Norway

About this study

Official title: 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)

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.

Read the 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.

Conditions: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer
Being tested: Trastuzumab deruxtecan
Keywords: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, Trastuzumab Deruxtecan, Enhertu®, HER2-(ultra)low Expressing Breast Cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trastuzumab deruxtecanDrug
Also called T-DXd
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.

Study groups in NCT05945732
Study group	Role	What they receive
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. Receives: Drug: Trastuzumab deruxtecan
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. Receives: Drug: Trastuzumab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer
Measured: Baseline up to approximately 37 months

Secondary outcomes (7)

Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer
Measured: 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)
Measured: 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)
Measured: Baseline up to approximately 37 months
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer
Measured: 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.
Measured: 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).
Measured: Baseline up to approximately 37 months
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary
Measured: Baseline up to approximately 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 202331 Dec 2030

First posted14 Jul 2023
Study start24 Oct 2023
Primary completion31 Dec 2030 (estimated)
Study completion31 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Unresectable Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 2,295 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05945732
Sponsor's protocol ID: DS8201-0005-NIS-MA
Status last verified: Aug 2026
First submitted: 6 Jul 2023
Last updated: 19 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 38592002

Interested in taking part?

Contact for Clinical Trial Information

908-992-6400

CTRinfo@dsi.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingPhase 1
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Breast Cancer, Ovarian Cancer

All Unresectable Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05945732
Acronym / sponsor ID: DS8201-0005-NIS-MA
Conditions: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer
Keywords: Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, Trastuzumab Deruxtecan, Enhertu®, HER2-(ultra)low Expressing Breast Cancer
Study type: Observational
Recruitment status: Recruiting
Enrolment: 2,295 participants (estimated)
Lead sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
Study start: 24 Oct 2023 (actual)
Primary completion: 31 Dec 2030 (estimated)
Study completion: 31 Dec 2030 (estimated)
First posted: 14 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Study Group 1	–	Drug: Trastuzumab deruxtecanAdult 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	–	Drug: Trastuzumab deruxtecanAdult 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (13 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trastuzumab deruxtecanAlso: T-DXdThis 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.	Drug	Study Group 1, Study Group 2

Primary outcome

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer
Time frame: Baseline up to approximately 37 months

7 secondary outcomes

Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer
Time frame: 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)
Time frame: 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)
Time frame: Baseline up to approximately 37 months
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer
Time frame: Baseline up to approximately 37 months
Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With Unresectable and/or Metastatic Breast Cancer
Time frame: 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
Time frame: Baseline up to approximately 37 months
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary
Time frame: Baseline up to approximately 37 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Derived from this study: PubMed 38592002Guarneri 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.
Individual participant dataSharing planned: No

Related trials for Unresectable Breast Cancer

RecruitingPhase 2/3
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
HER2-positive Breast Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingPhase 1
Immune Response Activation for the Treatment of Unresectable Metastatic Colorectal Cancer or CEA Positive Metastatic Breast Cancer
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 1
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
Breast Cancer, Ovarian Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Contact for Clinical Trial Information contact

908-992-6400

CTRinfo@dsi.com

Global Team Leader study director

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

216 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Unresectable Breast Cancer and Metastatic Breast Cancer, run by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company at 216 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in France, Spain, Italy, Belgium, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Clinical Trial Information (908-992-6400, CTRinfo@dsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer (time frame: Baseline up to approximately 37 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945732, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.