DESTINY Breast Respond HER2-low Europe
- Conditions
- Metastatic Breast CancerHER2-low Expressing Breast CancerUnresectable Breast Cancer
- Interventions
- Registration Number
- NCT05945732
- Lead Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- 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.
- Detailed Description
This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study.
Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1350
- Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
- Documented HER2-low status (IHC1+, IHC2+/ISH-)
- Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
- Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
- Written and signed Informed Consent to participate in the study
- 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 specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trastuzumab deruxtecan (T-DXd) Trastuzumab deruxtecan Participants with HER2-low expressing unresectable and/or metastatic breast cancer who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional chemotherapy. The participants on conventional chemotherapy will be analyzed exploratory only.
- Primary Outcome Measures
Name Time Method Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Baseline up to 31 months
- Secondary Outcome Measures
Name Time Method Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Baseline up to 31 months Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Baseline up to 31 months Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) Baseline up to 31 months Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only) Baseline up to 31 months Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Baseline up to 31 months The PGI-TT is designed to assess the treatment tolerability of the medicine. Participants will rate the bother associated with any treatment-related symptoms based on a 5-point scale ranging from 1 (not at all) to 5 (very much). Higher scores indicate a worse outcome.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Baseline up to 31 months The EORTC QLQ-C30 questionnaire is designed to measure cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 scales and single-item scales range in score from 0 to 100. A higher score for the functioning scales and global health status denotes a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary Baseline up to 31 months
Trial Locations
- Locations (197)
CH Cote Basque
🇫🇷Bayonne, France
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital de Getafe
🇪🇸Madrid, Spain
Hospital Virgen Arrixaca de Murcia
🇪🇸Murcia, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Complejo Asistencial Universitario de Palencia
🇪🇸Palencia, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
Hospital Son Llatzer
🇪🇸Palma, Spain
Hospital de Pontevedra
🇪🇸Pontevedra, Spain
Hospital San Joan de Reus
🇪🇸Reus, Spain
Hospital Universitari Parc Taulí
🇪🇸Sabadell, Spain
Hospital General de Catalunya
🇪🇸Sant Cugat del Vallès, Spain
Onkologikliniken Mälarsjukhuset
🇸🇪Eskilstuna, Sweden
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario General de Valencia
🇪🇸Valencia, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
Bröstcentrum, Karolinska Universitetssjukhuset Solna
🇸🇪Stockholm, Sweden
Complejo Hospitalario Universitario De Vigo
🇪🇸Vigo Pontevedra, Spain
Gävle Hospital
🇸🇪Gävle, Sweden
Ryhov County Hospital
🇸🇪Jönköping, Sweden
Capio St Görans sjukhus
🇸🇪Stockholm, Sweden
Onkologkliniken Sundsvalls Sjukhus
🇸🇪Sundsvall, Sweden
Department of Oncology, Västerås
🇸🇪Västerås, Sweden
Department of Oncology, Örebro University Hospital
🇸🇪Örebro, Sweden
Kantonsspital Baden
🇨🇭Baden, Switzerland
Spital Thurgau AG - Kantonsspital Frauenfeld
🇨🇭Frauenfeld, Switzerland
Centre du sein Fribourg
🇨🇭Fribourg, Switzerland
Clinique Generale-Beaulieu / Clinique de Genolier
🇨🇭Genève, Switzerland
Réseau Hospitalier Neuchâtelois (RHNe)
🇨🇭La Chaux-de-Fonds, Switzerland
Réseau du Sein Lausanne
🇨🇭Lausanne, Switzerland
CHUV
🇨🇭Lausanne, Switzerland
Kantonsspital Baselland
🇨🇭Liestal, Switzerland
Hôpital du Valais Sion
🇨🇭Sion, Switzerland
Kantonsspital St.Gallen
🇨🇭St. Gallen, Switzerland
ZIO AG
🇨🇭Zürich, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Medizinische Universität Graz
🇦🇹Graz, Austria
Hôpital Privé d'Antony
🇫🇷Antony, France
Hôpital Privé les Bonnettes
🇫🇷Arras, France
CHU de Limoges
🇫🇷Limoges, France
Hôpital Jean Mermoz
🇫🇷Lyon, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre d'oncologie Saint-Yves
🇫🇷Vannes, France
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Cancercentrum, Norrlands Universitetssjukhus
🇸🇪Umeå, Sweden
Landesklinikum Wiener Neustadt
🇦🇹Wiener Neustadt, Austria
Clinique de l'Europe
🇫🇷Amiens, France
Institut du Cancer Avignon Provence
🇫🇷Avignon, France
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
Klinikum Klagenfurt am Wörthersee
🇦🇹Klagenfurt am Wörthersee, Austria
LKH Hochsteiermark-Leoben
🇦🇹Leoben, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
🇦🇹Linz, Austria
Interne II, LKH Feldkirch
🇦🇹Rankweil, Austria
KH der Barmherzigen Brüder Salzburg
🇦🇹Salzburg, Austria
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
Salzkammergut Klinikum Vöcklabruck
🇦🇹Vöcklabruck, Austria
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
Medical University of Vienna
🇦🇹Wien, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Krankenhaus Hietzing
🇦🇹Wien, Austria
ASZ Aalst
🇧🇪Aalst, Belgium
Chirec Delta Hospital
🇧🇪Auderghem, Belgium
Imeldaziekenhuis Bonheiden
🇧🇪Bonheiden, Belgium
AZ Klina
🇧🇪Brasschaat, Belgium
AZ Sint-Jan Brugge av
🇧🇪Brugge, Belgium
CHU Brugmann
🇧🇪Brussels, Belgium
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium
Chu Helora- Hôpital de La Louvière- site Jolimont
🇧🇪Haine Saint Paul, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
CHU Tivoli
🇧🇪La Louviere, Belgium
Hôpital de la Citadelle
🇧🇪Liege, Belgium
CHC MontLegia
🇧🇪Liège, Belgium
CHU UCL Namur/Site Sainte Elisabeth
🇧🇪Namur, Belgium
Clinique Saint Pierre Ottignies
🇧🇪Ottignies, Belgium
VITAZ
🇧🇪Sint-Niklaas, Belgium
CHR Verviers East Belgium
🇧🇪Verviers, Belgium
Aalborg Universitetshospital, Syd
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus N, Denmark
Herlev Hospital
🇩🇰Herlev, Denmark
Onkologisk og Palliativ afdeling, Nordsjællands Hospital
🇩🇰Hillerød, Denmark
Naestved Hospital
🇩🇰Naestved, Denmark
Sygehus Sønderjylland, Sønderborg
🇩🇰Sønderborg, Denmark
CHU Amiens Picardie
🇫🇷Amiens, France
Centre Francois Baclesse
🇫🇷Caen, France
Pole Sante Leonard De Vinci
🇫🇷Chambray-lès-Tours, France
Clinique Belharra
🇫🇷Bayonne, France
Chu Jean Minjoz Besancon
🇫🇷Besançon, France
Clinique Tivoli-Ducos
🇫🇷Bordeaux, France
Centre Léonard de Vinci
🇫🇷Dechy, France
Centre hospitalier Fleyriat
🇫🇷Bourg-en-Bresse, France
CH Metropole Savoie
🇫🇷Chambéry, France
CH Cholet
🇫🇷Cholet, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Centre Hospitalier William Morey
🇫🇷Chalon-sur-Saône, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Polyclinique St Côme
🇫🇷Compiègne, France
CHU Martinique
🇫🇷Fort De France Cedex, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
CHI Frejus Saint Raphael
🇫🇷Fréjus, France
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
🇫🇷Grenoble, France
Polyclinique De Blois
🇫🇷La Chaussee Saint Victor, France
La Tronche - CHU Grenoble
🇫🇷La Tronche, France
Centre de cancerologie de la Sarthe
🇫🇷Le Mans, France
Centre Hospitalier Emile Roux
🇫🇷Le Puy-en-Velay, France
Hôpital Franco-Britannique Cognac Jay
🇫🇷Levallois-Perret, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU Lille
🇫🇷Lille, France
Hôpital Prive Le Bois
🇫🇷Lille, France
Hospices Civils De Lyon
🇫🇷Lyon, France
Hôpital-Clinique Claude Bernard
🇫🇷Metz, France
GH Havre
🇫🇷Montivilliers, France
Clinique Clementville
🇫🇷Montpellier, France
Groupe Hospitalier privé Ambroise Pare Hartmann
🇫🇷Neuilly-sur-Seine, France
Hopital Americain de Paris
🇫🇷Neuilly-sur-Seine, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre Hospitalier de Niort
🇫🇷Niort, France
Centre Médical ONCOGARD
🇫🇷NÎMES Cedex 9, France
Institut Curie
🇫🇷Paris, France
Groupement Hospitalier Diaconesses Croix Saint Simon
🇫🇷Paris, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hôpital Saint Joseph
🇫🇷Paris, France
CHU Poitiers
🇫🇷Poitiers, France
Institut Godinot
🇫🇷Reims, France
Polyclinique Courlancy
🇫🇷Reims, France
Clinique Saint Hilaire
🇫🇷Rouen, France
Clinique Mathilde
🇫🇷Rouen, France
Saint Cloud -Rene Huguenin Institut Curie
🇫🇷Saint-Cloud, France
CHU Réunion Site Sud
🇫🇷Saint-Paul, France
Institut De Cancerologie Paris Nord
🇫🇷Sarcelles, France
Centre Hospitalier de Sens
🇫🇷Sens Cédex, France
Hôpital Foch
🇫🇷Suresnes, France
CHR Metz Thionville
🇫🇷Thionville, France
HIA Sainte-Anne
🇫🇷Toulon, France
Centre Hospitalier de Troyes
🇫🇷Troyes, France
Hopital Prive Drome Ardeche
🇫🇷Valence, France
Nouvelle Clinique Des Dentellières
🇫🇷Valenciennes, France
Institut De Cancerologie De Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Médipôle Hôpital Mutualiste
🇫🇷Villeurbanne, France
Azienda Ospedaliera di Alessandria
🇮🇹Alessandria, Italy
Ospedale SS Annunziata
🇮🇹Chieti, Italy
Ospedale Citta' di Castello USL Umbria 1
🇮🇹Città di Castello, Italy
Ospedale San Giuseppe - Azienda USL Toscana Centro
🇮🇹Empoli, Italy
ASL Lecce - Ospedale "Vito Fazzi"
🇮🇹Lecce, Italy
ASST Lecco - PO "Alessandro Manzoni"
🇮🇹Lecco, Italy
AULSS 9 Scaligera - Ospedale Mater Salutis
🇮🇹Legnago, Italy
ASST Ovest Milanese - Ospedale di Legnano
🇮🇹Legnano, Italy
Ospedale Generale Provinciale di Macerata
🇮🇹Macerata, Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
🇮🇹Meldola, Italy
AOU di Modena
🇮🇹Modena, Italy
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Italy
AOU Federico II
🇮🇹Napoli, Italy
AOU Maggiore della Carità di Novara
🇮🇹Novara, Italy
IOV - Istituto Oncologico Veneto - IRCCS
🇮🇹Padova, Italy
La Maddalena S.p.A.
🇮🇹Palermo, Italy
ARNAS Ospedale Civico e Benfratelli
🇮🇹Palermo, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
AOU Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Italy
AO Regionale San Carlo
🇮🇹Potenza, Italy
GOM "BMM" - Presidio Ospedaliero Morelli
🇮🇹Reggio Calabria, Italy
Azienda USL IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
ASL RM 2 Ospedale Pertini
🇮🇹Roma, Italy
AO San Giovanni Addolorata
🇮🇹Roma, Italy
AOU "San Giovanni di Dio e Ruggi d'Aragona"
🇮🇹Salerno, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
AOU Sassari - Ospedale Civile SS. Annunziata
🇮🇹Sassari, Italy
Ospedale San Vincenzo
🇮🇹Taormina, Italy
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
🇮🇹Torino, Italy
AO Ordine Mauriziano
🇮🇹Torino, Italy
AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
🇮🇹Treviso, Italy
ASUFC Udine - Santa Maria della Misericordia
🇮🇹Udine, Italy
Drammen Sykehus
🇳🇴Drammen, Norway
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
🇮🇹Varese, Italy
Nordlandssjukhuset Bodø
🇳🇴Bodø, Norway
Sørlandet sykehus / Kristiansand Hospital
🇳🇴Kristiansand, Norway
Universitetssjukhuset Nord-Norge
🇳🇴Tromsø, Norway
Hospital Universitario de Basurto
🇪🇸Bilbao, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Universitario San Pedro de Alcántara
🇪🇸Cáceres, Spain
Sykehuset Telemark
🇳🇴Skien, Norway
Hospital Clinico Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Universitario de Puerto Real
🇪🇸Cádiz, Spain
Hospital Universitario de La Ribera
🇪🇸Alzira, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Hospital Clinico Universitario de Granada (PTS)
🇪🇸Granada, Spain
Hospital de Galdakao
🇪🇸Galdakao, Spain
Hospital Universitario Médico-Quirúrgico de Jaén
🇪🇸Jaén, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Spain
Complejo Asistencial Universitario de León
🇪🇸León, Spain
Hospital Universitario San Pedro de Logroño
🇪🇸Logroño, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario la Princesa
🇪🇸Madrid, Spain
Hospital MD Anderson Cancer Center
🇪🇸Madrid, Spain