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)
Status: Recruiting
Location: See all (216) locations...
Intervention Type: Drug
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Austria
Medizinische Universität Graz
RECRUITING
Graz
Medizinische Universität Graz
TERMINATED
Graz
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Klinikum Klagenfurt am Wörthersee
RECRUITING
Klagenfurt
LKH Hochsteiermark-Leoben
WITHDRAWN
Leoben
Ordensklinikum Linz GmbH Barmherzige Schwestern
RECRUITING
Linz
Interne II, LKH Feldkirch
ACTIVE_NOT_RECRUITING
Rankweil
KH der Barmherzigen Brüder Salzburg
RECRUITING
Salzburg
Uniklinikum Salzburg
RECRUITING
Salzburg
Krankenhaus Hietzing
RECRUITING
Vienna
Medical University of Vienna
RECRUITING
Vienna
Medizinische Universität Wien
TERMINATED
Vienna
Salzkammergut Klinikum Vöcklabruck
RECRUITING
Vöcklabruck
Klinikum Wels-Grieskirchen GmbH
ACTIVE_NOT_RECRUITING
Wels
Landesklinikum Wiener Neustadt
RECRUITING
Wiener Neustadt
Belgium
ASZ Aalst
ACTIVE_NOT_RECRUITING
Aalst
Chirec Delta Hospital
ACTIVE_NOT_RECRUITING
Auderghem
Imeldaziekenhuis Bonheiden
ACTIVE_NOT_RECRUITING
Bonheiden
AZ Klina
ACTIVE_NOT_RECRUITING
Brasschaat
AZ Sint-Jan Brugge av
ACTIVE_NOT_RECRUITING
Bruges
CHU Brugmann
ACTIVE_NOT_RECRUITING
Brussels
Cliniques universitaires Saint-Luc
ACTIVE_NOT_RECRUITING
Brussels
Chu Helora- Hôpital de La Louvière- site Jolimont
ACTIVE_NOT_RECRUITING
Haine-saint-paul
Jessa Ziekenhuis
ACTIVE_NOT_RECRUITING
Hasselt
CHU Tivoli
ACTIVE_NOT_RECRUITING
La Louvière
CHC MontLegia
ACTIVE_NOT_RECRUITING
Liège
Hôpital de la Citadelle
ACTIVE_NOT_RECRUITING
Liège
CHU UCL Namur/Site Sainte Elisabeth
ACTIVE_NOT_RECRUITING
Namur
Clinique Saint Pierre Ottignies
ACTIVE_NOT_RECRUITING
Ottignies
VITAZ
ACTIVE_NOT_RECRUITING
Sint-niklaas
CHR Verviers East Belgium
ACTIVE_NOT_RECRUITING
Verviers
Denmark
Aalborg Universitetshospital, Syd
TERMINATED
Aalborg
Aarhus University Hospital
ACTIVE_NOT_RECRUITING
Aarhus N
Herlev Hospital
ACTIVE_NOT_RECRUITING
Herlev
Onkologisk og Palliativ afdeling, Nordsjællands Hospital
ACTIVE_NOT_RECRUITING
Hillerød
Naestved Hospital
ACTIVE_NOT_RECRUITING
Næstved
Sygehus Sønderjylland, Sønderborg
TERMINATED
Sønderborg
France
CHU Amiens Picardie
ACTIVE_NOT_RECRUITING
Amiens
Clinique de l'Europe
ACTIVE_NOT_RECRUITING
Amiens
Hôpital Privé d'Antony
WITHDRAWN
Antony
Hôpital Privé les Bonnettes
ACTIVE_NOT_RECRUITING
Arras
Institut du Cancer Avignon Provence
ACTIVE_NOT_RECRUITING
Avignon
CH Cote Basque
ACTIVE_NOT_RECRUITING
Bayonne
Clinique Belharra
WITHDRAWN
Bayonne
Chu Jean Minjoz Besancon
ACTIVE_NOT_RECRUITING
Besançon
Clinique Tivoli-Ducos
ACTIVE_NOT_RECRUITING
Bordeaux
Centre hospitalier Fleyriat
ACTIVE_NOT_RECRUITING
Bourg-en-bresse
Centre Francois Baclesse
ACTIVE_NOT_RECRUITING
Caen
Centre Hospitalier William Morey
ACTIVE_NOT_RECRUITING
Chalon-sur-saône
CH Metropole Savoie
ACTIVE_NOT_RECRUITING
Chambéry
Pole Sante Leonard De Vinci
ACTIVE_NOT_RECRUITING
Chambray-lès-tours
CH Cholet
ACTIVE_NOT_RECRUITING
Cholet
Centre Jean Perrin
ACTIVE_NOT_RECRUITING
Clermont-ferrand
Polyclinique St Côme
ACTIVE_NOT_RECRUITING
Compiègne
Hôpital Henri Mondor
ACTIVE_NOT_RECRUITING
Créteil
Centre Léonard de Vinci
ACTIVE_NOT_RECRUITING
Dechy
Centre Georges Francois Leclerc
ACTIVE_NOT_RECRUITING
Dijon
CHU Martinique
ACTIVE_NOT_RECRUITING
Fort De France Cedex
CHI Frejus Saint Raphael
ACTIVE_NOT_RECRUITING
Fréjus
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
ACTIVE_NOT_RECRUITING
Grenoble
Polyclinique De Blois
WITHDRAWN
La Chaussée-saint-victor
La Tronche - CHU Grenoble
ACTIVE_NOT_RECRUITING
La Tronche
Centre de cancerologie de la Sarthe
ACTIVE_NOT_RECRUITING
Le Mans
Centre Hospitalier Emile Roux
ACTIVE_NOT_RECRUITING
Le Puy-en-velay
Hôpital Franco-Britannique Cognac Jay
ACTIVE_NOT_RECRUITING
Levallois-perret
Centre Oscar Lambret
ACTIVE_NOT_RECRUITING
Lille
CHU Lille
ACTIVE_NOT_RECRUITING
Lille
Hôpital Prive Le Bois
ACTIVE_NOT_RECRUITING
Lille
CHU de Limoges
ACTIVE_NOT_RECRUITING
Limoges
Hôpital Jean Mermoz
ACTIVE_NOT_RECRUITING
Lyon
Hospices Civils De Lyon
ACTIVE_NOT_RECRUITING
Lyon
Hôpital-Clinique Claude Bernard
WITHDRAWN
Metz
GH Havre
ACTIVE_NOT_RECRUITING
Montivilliers
Clinique Clementville
ACTIVE_NOT_RECRUITING
Montpellier
Groupe Hospitalier privé Ambroise Pare Hartmann
ACTIVE_NOT_RECRUITING
Neuilly-sur-seine
Hopital Americain de Paris
ACTIVE_NOT_RECRUITING
Neuilly-sur-seine
Centre Antoine Lacassagne
ACTIVE_NOT_RECRUITING
Nice
Centre Médical ONCOGARD
ACTIVE_NOT_RECRUITING
Nîmes
Centre Hospitalier de Niort
ACTIVE_NOT_RECRUITING
Niort
Groupement Hospitalier Diaconesses Croix Saint Simon
ACTIVE_NOT_RECRUITING
Paris
Hopital Europeen Georges Pompidou
ACTIVE_NOT_RECRUITING
Paris
Hôpital Saint Joseph
ACTIVE_NOT_RECRUITING
Paris
Institut Curie
ACTIVE_NOT_RECRUITING
Paris
Centre Hospitalier de Pau
ACTIVE_NOT_RECRUITING
Pau
CHU Poitiers
ACTIVE_NOT_RECRUITING
Poitiers
Institut Godinot
ACTIVE_NOT_RECRUITING
Reims
Polyclinique Courlancy
WITHDRAWN
Reims
Centre Eugene Marquis
ACTIVE_NOT_RECRUITING
Rennes
Clinique Mathilde
ACTIVE_NOT_RECRUITING
Rouen
Clinique Saint Hilaire
WITHDRAWN
Rouen
Saint Cloud -Rene Huguenin Institut Curie
WITHDRAWN
Saint-cloud
CHU Réunion Site Sud
ACTIVE_NOT_RECRUITING
Saint-paul
Institut De Cancerologie Paris Nord
ACTIVE_NOT_RECRUITING
Sarcelles
Centre Hospitalier de Sens
ACTIVE_NOT_RECRUITING
Sens Cédex
Hôpital Foch
ACTIVE_NOT_RECRUITING
Suresnes
CHR Metz Thionville
ACTIVE_NOT_RECRUITING
Thionville
HIA Sainte-Anne
ACTIVE_NOT_RECRUITING
Toulon
Centre Hospitalier de Troyes
WITHDRAWN
Troyes
Hopital Prive Drome Ardeche
ACTIVE_NOT_RECRUITING
Valence
Nouvelle Clinique Des Dentellières
ACTIVE_NOT_RECRUITING
Valenciennes
Institut De Cancerologie De Lorraine
WITHDRAWN
Vandœuvre-lès-nancy
Centre d'oncologie Saint-Yves
ACTIVE_NOT_RECRUITING
Vannes
Médipôle Hôpital Mutualiste
ACTIVE_NOT_RECRUITING
Villeurbanne
Italy
Azienda Ospedaliera di Alessandria
ACTIVE_NOT_RECRUITING
Alessandria
Ospedale SS Annunziata
ACTIVE_NOT_RECRUITING
Chieti
Ospedale Citta' di Castello USL Umbria 1
TERMINATED
Città Di Castello
Ospedale San Giuseppe - Azienda USL Toscana Centro
ACTIVE_NOT_RECRUITING
Empoli
ASL Lecce - Ospedale Vito Fazzi
WITHDRAWN
Lecce
ASST Lecco - PO Alessandro Manzoni
ACTIVE_NOT_RECRUITING
Lecco
AULSS 9 Scaligera - Ospedale Mater Salutis
ACTIVE_NOT_RECRUITING
Legnago
ASST Ovest Milanese - Ospedale di Legnano
ACTIVE_NOT_RECRUITING
Legnano
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST IRCCS
ACTIVE_NOT_RECRUITING
Meldola
AOU di Modena
ACTIVE_NOT_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
ACTIVE_NOT_RECRUITING
Monza
AOU Federico II
ACTIVE_NOT_RECRUITING
Naples
AOU Maggiore della Carità di Novara
ACTIVE_NOT_RECRUITING
Novara
IOV - Istituto Oncologico Veneto - IRCCS
ACTIVE_NOT_RECRUITING
Padova
ARNAS Ospedale Civico e Benfratelli
ACTIVE_NOT_RECRUITING
Palermo
La Maddalena S.p.A.
TERMINATED
Palermo
Fondazione IRCCS Policlinico San Matteo
ACTIVE_NOT_RECRUITING
Pavia
AOU Pisana - Stabilimento Santa Chiara
ACTIVE_NOT_RECRUITING
Pisa
AO Regionale San Carlo
ACTIVE_NOT_RECRUITING
Potenza
Ospedale Generale Provinciale di Macerata
ACTIVE_NOT_RECRUITING
Province Of Macerata
GOM BMM - Presidio Ospedaliero Morelli
ACTIVE_NOT_RECRUITING
Reggio Calabria
Azienda USL IRCCS di Reggio Emilia
ACTIVE_NOT_RECRUITING
Reggio Emilia
AO San Giovanni Addolorata
ACTIVE_NOT_RECRUITING
Roma
ASL RM 2 Ospedale Pertini
ACTIVE_NOT_RECRUITING
Roma
AOU San Giovanni di Dio e Ruggi d'Aragona
ACTIVE_NOT_RECRUITING
Salerno
IRCCS Ospedale Casa Sollievo della Sofferenza
ACTIVE_NOT_RECRUITING
San Giovanni Rotondo
AOU Sassari - Ospedale Civile SS. Annunziata
ACTIVE_NOT_RECRUITING
Sassari
Ospedale San Vincenzo
ACTIVE_NOT_RECRUITING
Taormina
AO Ordine Mauriziano
ACTIVE_NOT_RECRUITING
Torino
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
ACTIVE_NOT_RECRUITING
Torino
AULSS n. 2 Marca trevigiana - Ospedale Cà Foncello
ACTIVE_NOT_RECRUITING
Treviso
ASUFC Udine - Santa Maria della Misericordia
ACTIVE_NOT_RECRUITING
Udine
ASST Sette Laghi Ospedale di Circolo e Fondazione Macchi
ACTIVE_NOT_RECRUITING
Varese
Norway
Nordlandssjukhuset Bodø
RECRUITING
Bodø
Drammen Sykehus
RECRUITING
Drammen
Sørlandet sykehus / Kristiansand Hospital
ACTIVE_NOT_RECRUITING
Kristiansand
Sykehuset Telemark
RECRUITING
Skien
Universitetssjukhuset Nord-Norge
ACTIVE_NOT_RECRUITING
Tromsø
Portugal
Hospital de Cascais
WITHDRAWN
Alcabideche, Lisboa
ULS Amadora Sintra
WITHDRAWN
Amadora, Lisboa
ULS Braga
WITHDRAWN
Braga
Dra. Berta Sousa
WITHDRAWN
Lisbon
Hospital da Luz Lisboa
WITHDRAWN
Lisbon
IPO Lisboa
WITHDRAWN
Lisbon
ULS Santa Maria
WITHDRAWN
Lisbon
ULS Loures-Odivelas - Hospital Beatriz Ângelo
WITHDRAWN
Loures
Instituto Português de Oncologia do Porto Francisco Gentil
WITHDRAWN
Porto
ULS Matosinhos
WITHDRAWN
Porto
ULS Santo António
WITHDRAWN
Porto
ULS Trás-os-Montes e Alto Douro
WITHDRAWN
Vila Real
Spain
Hospital Clinico Universitario de Albacete
ACTIVE_NOT_RECRUITING
Albacete
Hospital General Universitario de Alicante
NOT_YET_RECRUITING
Alicante
Hospital Universitario de La Ribera
ACTIVE_NOT_RECRUITING
Alzira
Hospital Universitario de Cruces
TERMINATED
Barakaldo
Hosp. Univ. de Bellvitge - Ico Hospitalet - Duran I Reynals
NOT_YET_RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario de Basurto
ACTIVE_NOT_RECRUITING
Bilbao
Hospital Universitario San Pedro de Alcántara
ACTIVE_NOT_RECRUITING
Cáceres
Hospital Universitario de Puerto Real
ACTIVE_NOT_RECRUITING
Cadiz
Hospital Universitario Reina Sofia
ACTIVE_NOT_RECRUITING
Córdoba
Hospital General Universitario de Elche
ACTIVE_NOT_RECRUITING
Elche
Hospital de Galdakao
ACTIVE_NOT_RECRUITING
Galdakao
Hospital Clinico Universitario de Granada (PTS)
ACTIVE_NOT_RECRUITING
Granada
Hospital Universitario Médico-Quirúrgico de Jaén
ACTIVE_NOT_RECRUITING
Jaén
Complejo Asistencial Universitario de León
TERMINATED
León
Hospital Universitario San Pedro de Logroño
WITHDRAWN
Logroño
Hospital Universitario Lucus Augusti
ACTIVE_NOT_RECRUITING
Lugo
Hospital Clínico Universitario San Carlos
ACTIVE_NOT_RECRUITING
Madrid
Hospital de Getafe
ACTIVE_NOT_RECRUITING
Madrid
Hospital MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario la Princesa
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Hospital Virgen Arrixaca de Murcia
ACTIVE_NOT_RECRUITING
Murcia
Hospital Universitario Central de Asturias
ACTIVE_NOT_RECRUITING
Oviedo
Complejo Asistencial Universitario de Palencia
TERMINATED
Palencia
Hospital Son Llatzer
TERMINATED
Palma
Hospital Son Espases
ACTIVE_NOT_RECRUITING
Palma De Mallorca
Hospital de Pontevedra
ACTIVE_NOT_RECRUITING
Pontevedra
Hospital San Joan de Reus
ACTIVE_NOT_RECRUITING
Reus
Hospital Universitari Parc Taulí
ACTIVE_NOT_RECRUITING
Sabadell
Complejo Asistencial Universitario de Salamanca
TERMINATED
Salamanca
Hospital Universitario de Canarias
ACTIVE_NOT_RECRUITING
San Cristóbal De La Laguna
Hospital General de Catalunya
ACTIVE_NOT_RECRUITING
Sant Cugat Del Vallès
Hospital Universitario Marqués de Valdecilla
ACTIVE_NOT_RECRUITING
Santander
Hospital Universitario General de Valencia
ACTIVE_NOT_RECRUITING
Valencia
Hospital Clínico de Valladolid
ACTIVE_NOT_RECRUITING
Valladolid
Hospital Universitario Rio Hortega
ACTIVE_NOT_RECRUITING
Valladolid
Complejo Hospitalario Universitario De Vigo
ACTIVE_NOT_RECRUITING
Vigo Pontevedra
Hospital Clínico Universitario Lozano Blesa
NOT_YET_RECRUITING
Zaragoza
Sweden
Onkologikliniken Mälarsjukhuset
RECRUITING
Eskilstuna
Gävle Hospital
RECRUITING
Gävle
Ryhov County Hospital
ACTIVE_NOT_RECRUITING
Jönköping
Department of Oncology, Örebro University Hospital
RECRUITING
Örebro
Bröstcentrum, Karolinska Universitetssjukhuset Solna
ACTIVE_NOT_RECRUITING
Stockholm
Capio St Görans sjukhus
ACTIVE_NOT_RECRUITING
Stockholm
Onkologkliniken Sundsvalls Sjukhus
WITHDRAWN
Sundsvall
Cancercentrum, Norrlands Universitetssjukhus
RECRUITING
Umeå
Department of Oncology, Västerås
RECRUITING
Västerås
Switzerland
Kantonsspital Baden
RECRUITING
Baden
Spital Thurgau AG - Kantonsspital Frauenfeld
TERMINATED
Frauenfeld
Centre du sein Fribourg
RECRUITING
Fribourg
Clinique Generale-Beaulieu / Clinique de Genolier
RECRUITING
Geneva
Réseau Hospitalier Neuchâtelois (RHNe)
RECRUITING
La Chaux-de-fonds
CHUV
RECRUITING
Lausanne
Réseau du Sein Lausanne
RECRUITING
Lausanne
Kantonsspital Baselland
RECRUITING
Liestal
Kantonsspital St.Gallen
NOT_YET_RECRUITING
Sankt Gallen
Hôpital du Valais Sion
TERMINATED
Sion
Universitätsspital Zürich
RECRUITING
Zurich
ZIO AG
ACTIVE_NOT_RECRUITING
Zurich
Contact Information
Primary
Contact for Clinical Trial Information
CTRinfo@dsi.com
908-992-6400
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 2295
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company