Clinical trial NCT05945732: DESTINY Breast Respond HER2-low Europe
Official title: A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-low Europe)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable Breast Cancer
Metastatic Breast Cancer
HER2-low Expressing Breast Cancer
Keywords: Unresectable Breast Cancer
Metastatic Breast Cancer
HER2-low Expressing Breast Cancer
Trastuzumab Deruxtecan
Enhertu®
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
timeFrame: Baseline up to 31 months
Secondary outcomes:
measure: Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
timeFrame: Baseline up to 31 months
measure: Number of Physician-reported Safety Events of Interest in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer (T-DXd only)
timeFrame: Baseline up to 31 months
measure: 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)
timeFrame: Baseline up to 31 months
measure: Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
timeFrame: Baseline up to 31 months
measure: Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
timeFrame: Baseline up to 31 months
measure: 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
timeFrame: Baseline up to 31 months
measure: Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary
timeFrame: Baseline up to 31 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Leoben
country: Austria
facility: LKH Hochsteiermark-Leoben
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Rankweil
country: Austria
facility: Interne II, LKH Feldkirch
city: Salzburg
country: Austria
facility: KH der Barmherzigen Brüder Salzburg
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
city: Vöcklabruck
country: Austria
facility: Salzkammergut Klinikum Vöcklabruck
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Wien
country: Austria
facility: Medical University of Vienna
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Auderghem
country: Belgium
facility: Chirec Delta Hospital
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis Bonheiden
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge av
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Haine Saint Paul
country: Belgium
facility: Chu Helora- Hôpital de La Louvière- site Jolimont
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: La Louviere
country: Belgium
facility: CHU Tivoli
city: Liege
country: Belgium
facility: Hôpital de la Citadelle
city: Liège
country: Belgium
facility: CHC MontLegia
city: Namur
country: Belgium
facility: CHU UCL Namur/Site Sainte Elisabeth
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre Ottignies
city: Sint-Niklaas
country: Belgium
facility: VITAZ
city: Verviers
country: Belgium
facility: CHR Verviers East Belgium
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Syd
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Hillerød
country: Denmark
facility: Onkologisk og Palliativ afdeling, Nordsjællands Hospital
city: Naestved
country: Denmark
facility: Naestved Hospital
city: Sønderborg
country: Denmark
facility: Sygehus Sønderjylland, Sønderborg
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Amiens
country: France
facility: Clinique de l'Europe
city: Antony
country: France
facility: Hôpital Privé d'Antony
city: Arras
country: France
facility: Hôpital Privé les Bonnettes
city: Avignon
country: France
facility: Institut du Cancer Avignon Provence
city: Bayonne
country: France
facility: CH Cote Basque
city: Bayonne
country: France
facility: Clinique Belharra
city: Besançon
country: France
facility: Chu Jean Minjoz Besancon
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Bourg-en-Bresse
country: France
facility: Centre hospitalier Fleyriat
city: Caen
country: France
facility: Centre Francois Baclesse
city: Chalon-sur-Saône
country: France
facility: Centre Hospitalier William Morey
city: Chambray-lès-Tours
country: France
facility: Pole Sante Leonard De Vinci
city: Chambéry
country: France
facility: CH Metropole Savoie
city: Cholet
country: France
facility: CH Cholet
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Compiègne
country: France
facility: Polyclinique St Côme
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dechy
country: France
facility: Centre Léonard de Vinci
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Fort De France Cedex
country: France
facility: CHU Martinique
city: Fréjus
country: France
facility: CHI Frejus Saint Raphael
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
city: La Chaussee Saint Victor
country: France
facility: Polyclinique De Blois
city: La Tronche
country: France
facility: La Tronche - CHU Grenoble
city: Le Mans
country: France
facility: Centre de cancerologie de la Sarthe
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Levallois-Perret
country: France
facility: Hôpital Franco-Britannique Cognac Jay
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: CHU Lille
city: Lille
country: France
facility: Hôpital Prive Le Bois
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: Hospices Civils De Lyon
city: Lyon
country: France
facility: Hôpital Jean Mermoz
city: Metz
country: France
facility: Hôpital-Clinique Claude Bernard
city: Montivilliers
country: France
facility: GH Havre
city: Montpellier
country: France
facility: Clinique Clementville
city: Neuilly-sur-Seine
country: France
facility: Groupe Hospitalier privé Ambroise Pare Hartmann
city: Neuilly-sur-Seine
country: France
facility: Hopital Americain de Paris
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Niort
country: France
facility: Centre Hospitalier de Niort
city: NÎMES Cedex 9
country: France
facility: Centre Médical ONCOGARD
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Groupement Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Godinot
city: Reims
country: France
facility: Polyclinique Courlancy
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Rouen
country: France
facility: Clinique Mathilde
city: Saint-Cloud
country: France
facility: Saint Cloud -Rene Huguenin Institut Curie
city: Saint-Paul
country: France
facility: CHU Réunion Site Sud
city: Sarcelles
country: France
facility: Institut De Cancerologie Paris Nord
city: Sens Cédex
country: France
facility: Centre Hospitalier de Sens
city: Suresnes
country: France
facility: Hôpital Foch
city: Thionville
country: France
facility: CHR Metz Thionville
city: Toulon
country: France
facility: HIA Sainte-Anne
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Valence
country: France
facility: Hopital Prive Drome Ardeche
city: Valenciennes
country: France
facility: Nouvelle Clinique Des Dentellières
city: Vandœuvre-lès-Nancy
country: France
facility: Institut De Cancerologie De Lorraine
city: Vannes
country: France
facility: Centre d'oncologie Saint-Yves
city: Villeurbanne
country: France
facility: Médipôle Hôpital Mutualiste
city: Alessandria
country: Italy
facility: Azienda Ospedaliera di Alessandria
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
city: Città di Castello
country: Italy
facility: Ospedale Citta' di Castello USL Umbria 1
city: Empoli
country: Italy
facility: Ospedale San Giuseppe - Azienda USL Toscana Centro
city: Lecce
country: Italy
facility: ASL Lecce - Ospedale "Vito Fazzi"
city: Lecco
country: Italy
facility: ASST Lecco - PO "Alessandro Manzoni"
city: Legnago
country: Italy
facility: AULSS 9 Scaligera - Ospedale Mater Salutis
city: Legnano
country: Italy
facility: ASST Ovest Milanese - Ospedale di Legnano
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale di Macerata
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
city: Modena
country: Italy
facility: AOU di Modena
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Napoli
country: Italy
facility: AOU Federico II
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS
city: Palermo
country: Italy
facility: La Maddalena S.p.A.
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico e Benfratelli
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: AOU Pisana - Stabilimento Santa Chiara
city: Potenza
country: Italy
facility: AO Regionale San Carlo
city: Reggio Calabria
country: Italy
facility: GOM "BMM" - Presidio Ospedaliero Morelli
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: ASL RM 2 Ospedale Pertini
city: Roma
country: Italy
facility: AO San Giovanni Addolorata
city: Salerno
country: Italy
facility: AOU "San Giovanni di Dio e Ruggi d'Aragona"
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Sassari
country: Italy
facility: AOU Sassari - Ospedale Civile SS. Annunziata
city: Taormina
country: Italy
facility: Ospedale San Vincenzo
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Treviso
country: Italy
facility: AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
city: Udine
country: Italy
facility: ASUFC Udine - Santa Maria della Misericordia
city: Varese
country: Italy
facility: ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
city: Bodø
country: Norway
facility: Nordlandssjukhuset Bodø
city: Drammen
country: Norway
facility: Drammen Sykehus
city: Kristiansand
country: Norway
facility: Sørlandet sykehus / Kristiansand Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark
city: Tromsø
country: Norway
facility: Universitetssjukhuset Nord-Norge
city: Albacete
country: Spain
facility: Hospital Clinico Universitario de Albacete
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Cáceres
country: Spain
facility: Hospital Universitario San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Universitario de Puerto Real
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Galdakao
country: Spain
facility: Hospital de Galdakao
city: Granada
country: Spain
facility: Hospital Clinico Universitario de Granada (PTS)
city: Jaén
country: Spain
facility: Hospital Universitario Médico-Quirúrgico de Jaén
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Logroño
country: Spain
facility: Hospital Universitario San Pedro de Logroño
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Madrid
country: Spain
facility: Hospital MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital de Getafe
city: Murcia
country: Spain
facility: Hospital Virgen Arrixaca de Murcia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palencia
country: Spain
facility: Complejo Asistencial Universitario de Palencia
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Palma
country: Spain
facility: Hospital Son Llatzer
city: Pontevedra
country: Spain
facility: Hospital de Pontevedra
city: Reus
country: Spain
facility: Hospital San Joan de Reus
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
city: Sant Cugat del Vallès
country: Spain
facility: Hospital General de Catalunya
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitario General de Valencia
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Vigo Pontevedra
country: Spain
facility: Complejo Hospitalario Universitario De Vigo
city: Eskilstuna
country: Sweden
facility: Onkologikliniken Mälarsjukhuset
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Jönköping
country: Sweden
facility: Ryhov County Hospital
city: Stockholm
country: Sweden
facility: Capio St Görans sjukhus
city: Stockholm
country: Sweden
facility: Bröstcentrum, Karolinska Universitetssjukhuset Solna
city: Sundsvall
country: Sweden
facility: Onkologkliniken Sundsvalls Sjukhus
city: Umeå
country: Sweden
facility: Cancercentrum, Norrlands Universitetssjukhus
city: Västerås
country: Sweden
facility: Department of Oncology, Västerås
city: Örebro
country: Sweden
facility: Department of Oncology, Örebro University Hospital
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Frauenfeld
country: Switzerland
facility: Spital Thurgau AG - Kantonsspital Frauenfeld
city: Fribourg
country: Switzerland
facility: Centre du sein Fribourg
city: Genève
country: Switzerland
facility: Clinique Generale-Beaulieu / Clinique de Genolier
city: La Chaux-de-Fonds
country: Switzerland
facility: Réseau Hospitalier Neuchâtelois (RHNe)
city: Lausanne
country: Switzerland
facility: Réseau du Sein Lausanne
city: Lausanne
country: Switzerland
facility: CHUV
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Sion
country: Switzerland
facility: Hôpital du Valais Sion
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zürich
country: Switzerland
facility: ZIO AG
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
name: Global Team Leader
role: STUDY_DIRECTOR
References: