DESTINY Breast Respond HER2-low Europe

March 6, 2024 updated by: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Contact for Clinical Trial Information
  • Phone Number: 908-992-6400
  • Email: CTRinfo@dsi.com

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Not yet recruiting
        • Medizinische Universität Graz
        • Contact:
          • Principal Investigator
      • Graz, Austria, 8036
        • Terminated
        • Medizinische Universität Graz
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universität Innsbruck
      • Linz, Austria, 4010
        • Not yet recruiting
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
        • Contact:
          • Principal Investigator
      • Rankweil, Austria, 6830
        • Recruiting
        • Interne II, LKH Feldkirch
        • Contact:
          • Principal Investigator
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg
        • Contact:
          • Principal Investigator
      • Salzburg, Austria, 5010
        • Recruiting
        • KH der Barmherzigen Brüder Salzburg
        • Contact:
          • Principal Investigator
      • Vöcklabruck, Austria, 4840
        • Not yet recruiting
        • Salzkammergut Klinikum Vöcklabruck
        • Contact:
          • Principal Investigator
      • Wels, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen GmbH
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1130
        • Not yet recruiting
        • Krankenhaus Hietzing
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1090
        • Not yet recruiting
        • Medical University of Vienna
        • Contact:
          • Principal Investigator
      • Wien, Austria, 1090
        • Terminated
        • Medizinische Universität Wien
      • Wiener Neustadt, Austria, 2700
        • Not yet recruiting
        • Landesklinikum Wiener Neustadt
        • Contact:
          • Principal Investigator
  • Belgium
      • Aalst, Belgium, 9300
        • Not yet recruiting
        • ASZ Aalst
        • Contact:
          • Principal Investigator
      • Bonheiden, Belgium, 2820
        • Not yet recruiting
        • Imeldaziekenhuis Bonheiden
        • Contact:
          • Principal Investigator
      • Brasschaat, Belgium, 2930
        • Not yet recruiting
        • AZ Klina
        • Contact:
          • Principal Investigator
      • Brugge, Belgium, 8000
        • Not yet recruiting
        • AZ Sint-Jan Brugge av
        • Contact:
          • Principal Investigator
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Principal Investigator
      • Brussels, Belgium, 1020
        • Not yet recruiting
        • CHU Brugmann
        • Contact:
          • Principal Investigator
      • Haine Saint Paul, Belgium, 7100
        • Not yet recruiting
        • Chu Helora- Hôpital de La Louvière- site Jolimont
        • Contact:
          • Principal Investigator
      • La Louviere, Belgium, 7100
        • Not yet recruiting
        • CHU Tivoli
        • Contact:
          • Principal Investigator
      • Liege, Belgium, 4000
        • Not yet recruiting
        • Hôpital de la Citadelle
        • Contact:
          • Principal Investigator
      • Namur, Belgium, B5000
        • Not yet recruiting
        • CHU UCL Namur/Site Sainte Elisabeth
        • Contact:
          • Principal Investigator
      • Ottignies, Belgium, 1340
        • Not yet recruiting
        • Clinique Saint Pierre Ottignies
        • Contact:
          • Principal Investigator
      • Sint-Niklaas, Belgium, 9100
        • Not yet recruiting
        • VITAZ
        • Contact:
          • Principal Investigator
      • Verviers, Belgium, 4800
        • Not yet recruiting
        • CHR Verviers East Belgium
        • Contact:
          • Principal Investigator
  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Aalborg Universitetshospital, Syd
        • Contact:
          • Principal Investigator
      • Aarhus N, Denmark, 8200
        • Not yet recruiting
        • Aarhus University Hospital
        • Contact:
          • Principal Investigator
      • Sønderborg, Denmark, 6400
        • Not yet recruiting
        • Sygehus Sønderjylland, Sønderborg
        • Contact:
          • Principal Investigator
  • France
      • Amiens, France, 80000
        • Not yet recruiting
        • CHU Amiens Picardie
        • Contact:
          • Principal Investigator
      • Amiens, France, 80090
        • Not yet recruiting
        • Clinique de l'Europe
        • Contact:
          • Principal Investigator
      • Avignon, France, 84918
        • Not yet recruiting
        • Institut du Cancer Avignon Provence
        • Contact:
          • Principal Investigator
      • Bayonne, France, 64100
        • Not yet recruiting
        • CH Cote Basque
        • Contact:
          • Principal Investigator
      • Bayonne, France, 64100
        • Not yet recruiting
        • Clinique Belharra
        • Contact:
          • Principal Investigator
      • Besançon, France, 25000
        • Not yet recruiting
        • Chu Jean Minjoz Besancon
        • Contact:
          • Principal Investigator
      • Bordeaux, France, 33000
        • Not yet recruiting
        • Clinique Tivoli-Ducos
        • Contact:
          • Principal Investigator
      • Bourg-en-Bresse, France, 01012
        • Not yet recruiting
        • Centre Hospitalier Fleyriat
        • Contact:
          • Principal Investigator
      • Caen, France, 14000
        • Not yet recruiting
        • Centre François Baclesse
        • Contact:
          • Principal Investigator
      • Chalon-sur-Saône, France, 71321
        • Not yet recruiting
        • Centre Hospitalier William Morey
        • Contact:
          • Principal Investigator
      • Chambray-lès-Tours, France, 37170
        • Not yet recruiting
        • Pole Sante Leonard de Vinci
        • Contact:
          • Principal Investigator
      • Chambéry, France, 73000
        • Not yet recruiting
        • CH Metropole Savoie
        • Contact:
          • Principal Investigator
      • Cholet, France, 49300
        • Not yet recruiting
        • Ch Cholet
        • Contact:
          • Principal Investigator
      • Clermont-Ferrand, France, 63011
        • Not yet recruiting
        • Centre Jean Perrin
        • Contact:
          • Principal Investigator
      • Compiègne, France, 60200
        • Not yet recruiting
        • Polyclinique St Côme
        • Contact:
          • Principal Investigator
      • Créteil, France, 94000
        • Not yet recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Principal Investigator
      • Dechy, France, 59187
        • Not yet recruiting
        • Centre Leonard de Vinci
        • Contact:
          • Principal Investigator
      • Dijon, France, 21000
        • Not yet recruiting
        • Centre Georges Francois Leclerc
        • Contact:
          • Principal Investigator
      • Fort De France Cedex, France, 97261
        • Not yet recruiting
        • CHU Martinique
        • Contact:
          • Principal Investigator
      • Fréjus, France, 83600
        • Not yet recruiting
        • CHI Frejus Saint Raphael
        • Contact:
          • Principal Investigator
      • Grenoble, France, 38000
        • Not yet recruiting
        • Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
        • Contact:
          • Principal Investigator
      • La Chaussee Saint Victor, France, 41260
        • Not yet recruiting
        • Polyclinique De Blois
        • Contact:
          • Principal Investigator
      • La Tronche, France, 38700
        • Not yet recruiting
        • La Tronche - CHU Grenoble
        • Contact:
          • Principal Investigator
      • Le Mans, France, 72100
        • Not yet recruiting
        • Centre de cancerologie de la Sarthe
        • Contact:
          • Principal Investigator
      • Le Puy-en-Velay, France, 43000
        • Not yet recruiting
        • Centre Hospitalier Emile Roux
        • Contact:
          • Principal Investigator
      • Lille, France, 59000
        • Not yet recruiting
        • Centre Oscar Lambret
        • Contact:
          • Principal Investigator
      • Lille, France, 59000
        • Not yet recruiting
        • CHU Lille
        • Contact:
          • Principal Investigator
      • Lille, France, 59000
        • Not yet recruiting
        • Hôpital privé Le Bois
        • Contact:
          • Principal Investigator
      • Lyon, France, 69002
        • Not yet recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Principal Investigator
      • Metz, France, 57070
        • Not yet recruiting
        • Hôpital-Clinique Claude Bernard
        • Contact:
          • Principal Investigator
      • Montivilliers, France, 76920
        • Not yet recruiting
        • GH Havre
        • Contact:
          • Principal Investigator
      • Montpellier, France, 34070
        • Not yet recruiting
        • Clinique Clémentville
        • Contact:
          • Principal Investigator
      • Neuilly-sur-Seine, France, 92200
        • Not yet recruiting
        • Hôpital Américain de Paris
        • Contact:
          • Principal Investigator
      • Neuilly-sur-Seine, France, 92200
        • Not yet recruiting
        • Groupe Hospitalier privé Ambroise Pare Hartmann
        • Contact:
          • Principal Investigator
      • Nice, France, 06100
        • Not yet recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Principal Investigator
      • Niort, France, 79000
        • Not yet recruiting
        • Centre Hospitalier de Niort
        • Contact:
          • Principal Investigator
      • NÎMES Cedex 9, France, 30029
        • Not yet recruiting
        • Centre Médical ONCOGARD
        • Contact:
          • Principal Investigator
      • Paris, France, 75015
        • Not yet recruiting
        • Hôpital Européen Georges Pompidou
        • Contact:
          • Principal Investigator
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie
        • Contact:
          • Principal Investigator
      • Paris, France, 75012
        • Not yet recruiting
        • Groupement Hospitalier Diaconesses Croix Saint Simon
        • Contact:
          • Principal Investigator
      • Paris, France, 75103
        • Not yet recruiting
        • Hôpital Saint Joseph
        • Contact:
          • Principal Investigator
      • Poitiers, France, 86000
        • Not yet recruiting
        • CHU Poitiers
        • Contact:
          • Principal Investigator
      • Reims, France, 51100
        • Not yet recruiting
        • Institut Godinot
        • Contact:
          • Principal Investigator
      • Reims, France, 51100
        • Not yet recruiting
        • Polyclinique Courlancy
        • Contact:
          • Principal Investigator
      • Rouen, France, 76000
        • Not yet recruiting
        • Clinique Saint Hilaire
        • Contact:
          • Principal Investigator
      • Rouen, France, 76100
        • Not yet recruiting
        • Clinique Mathilde
        • Contact:
          • Principal Investigator
      • Saint-Cloud, France, 92210
        • Not yet recruiting
        • Saint Cloud -Rene Huguenin Institut Curie
        • Contact:
          • Principal Investigator
      • Saint-Paul, France, 97460
        • Not yet recruiting
        • CHU Réunion Site Sud
        • Contact:
          • Principal Investigator
      • Sarcelles, France, 95200
        • Not yet recruiting
        • Institut de Cancérologie Paris Nord
        • Contact:
          • Principal Investigator
      • Sens Cédex, France, 89108
        • Not yet recruiting
        • Centre Hospitalier de Sens
        • Contact:
          • Principal Investigator
      • Suresnes, France, 92150
        • Not yet recruiting
        • Hopital FOCH
        • Contact:
          • Principal Investigator
      • Thionville, France, 57100
        • Not yet recruiting
        • CHR Metz Thionville
        • Contact:
          • Principal Investigator
      • Toulon, France, 83000
        • Not yet recruiting
        • HIA Sainte-Anne
        • Contact:
          • Principal Investigator
      • Troyes, France, 10000
        • Not yet recruiting
        • Centre Hospitalier de Troyes
        • Contact:
          • Principal Investigator
      • Valence, France, 26000
        • Not yet recruiting
        • Hôpital Privé Drôme Ardèche
        • Contact:
          • Principal Investigator
      • Valenciennes, France, 59300
        • Not yet recruiting
        • Nouvelle Clinique Des Dentellières
        • Contact:
          • Principal Investigator
      • Vandœuvre-lès-Nancy, France, 54519
        • Not yet recruiting
        • Institut de Cancérologie de Lorraine
        • Contact:
          • Principal Investigator
      • Villeurbanne, France, 69100
        • Not yet recruiting
        • Médipôle Hôpital Mutualiste
        • Contact:
          • Principal Investigator
  • Italy
      • Alessandria, Italy, 15121
        • Not yet recruiting
        • Azienda Ospedaliera di Alessandria
        • Contact:
          • Principal Investigator
      • Chieti, Italy, 66100
        • Not yet recruiting
        • Ospedale SS Annunziata
        • Contact:
          • Principal Investigator
      • Città di Castello, Italy, 06012
        • Not yet recruiting
        • Ospedale Citta' di Castello USL Umbria 1
        • Contact:
          • Principal Investigator
      • Empoli, Italy, 50053
        • Not yet recruiting
        • Ospedale San Giuseppe - Azienda USL Toscana Centro
        • Contact:
          • Principal Investigator
      • Lecco, Italy, 23900
        • Not yet recruiting
        • ASST Lecco - PO "Alessandro Manzoni"
        • Contact:
          • Principal Investigator
      • Legnago, Italy, 37045
        • Not yet recruiting
        • AULSS 9 Scaligera - Ospedale Mater Salutis
        • Contact:
          • Principal Investigator
      • Macerata, Italy, 62100
        • Not yet recruiting
        • Ospedale Generale Provinciale di Macerata
        • Contact:
          • Principal Investigator
      • Meldola, Italy, 47014
        • Not yet recruiting
        • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
        • Contact:
          • Principal Investigator
      • Monza, Italy, 20900
        • Not yet recruiting
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Principal Investigator
      • Napoli, Italy, 80131
        • Not yet recruiting
        • AOU Federico II
        • Contact:
          • Principal Investigator
      • Novara, Italy, 28100
        • Not yet recruiting
        • AOU Maggiore della Carità di Novara
        • Contact:
          • Principal Investigator
      • Padova, Italy, 35128
        • Not yet recruiting
        • IOV - Istituto Oncologico Veneto - IRCCS
        • Contact:
          • Principal Investigator
      • Palermo, Italy, 90124
        • Not yet recruiting
        • ARNAS Ospedale Civico e Benfratelli
        • Contact:
          • Principal Investigator
      • Pavia, Italy, 27100
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
          • Principal Investigator
      • Potenza, Italy, 85100
        • Not yet recruiting
        • AO Regionale San Carlo
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00184
        • Not yet recruiting
        • AO San Giovanni Addolorata
        • Contact:
          • Principal Investigator
      • Roma, Italy, 00157
        • Not yet recruiting
        • ASL RM 2 Ospedale Pertini
        • Contact:
          • Principal Investigator
      • Salerno, Italy, 84135
        • Not yet recruiting
        • AOU "San Giovanni di Dio e Ruggi d'Aragona"
        • Contact:
          • Principal Investigator
      • Taormina, Italy, 98039
        • Not yet recruiting
        • Ospedale San Vincenzo
        • Contact:
          • Principal Investigator
      • Torino, Italy, 10126
        • Not yet recruiting
        • AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
        • Contact:
          • Principal Investigator
      • Torino, Italy, 10128
        • Not yet recruiting
        • AO Ordine Mauriziano
        • Contact:
          • Principal Investigator
      • Udine, Italy, 33100
        • Not yet recruiting
        • ASUFC Udine - Santa Maria della Misericordia
        • Contact:
          • Principal Investigator
      • Varese, Italy, 22100
        • Not yet recruiting
        • ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
        • Contact:
          • Principal Investigator
  • Norway
      • Tromsø, Norway, 9019
        • Not yet recruiting
        • Universitetssjukhuset Nord-Norge
        • Contact:
          • Principal Investigator
  • Spain
      • Albacete, Spain, 02006
        • Not yet recruiting
        • Hospital Clinico Universitario de Albacete
        • Contact:
          • Principal Investigator
      • Alzira, Spain, 46600
        • Not yet recruiting
        • Hospital Universitario de La Ribera
        • Contact:
          • Principal Investigator
      • Bilbao, Spain, 48013
        • Not yet recruiting
        • Hospital Universitario de Basurto
        • Contact:
          • Principal Investigator
      • Cordoba, Spain, 14004
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Principal Investigator
      • Cáceres, Spain, 10003
        • Not yet recruiting
        • Hospital Universitario San Pedro de Alcántara
        • Contact:
          • Principal Investigator
      • Cádiz, Spain, 11510
        • Not yet recruiting
        • Hospital Universitario de Puerto Real
        • Contact:
          • Principal Investigator
      • Granada, Spain, 18016
        • Not yet recruiting
        • Hospital Clinico Universitario de Granada (PTS)
        • Contact:
          • Principal Investigator
      • La Laguna, Spain, 38320
        • Not yet recruiting
        • Hospital Universitario de Canarias
        • Contact:
          • Principal Investigator
      • León, Spain, 24008
        • Not yet recruiting
        • Complejo Asistencial Universitario de León
        • Contact:
          • Principal Investigator
      • Lugo, Spain, 270003
        • Not yet recruiting
        • Hospital Universitario Lucus Augusti
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon Y Cajal
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28033
        • Not yet recruiting
        • Hospital MD Anderson Cancer Center
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Hospital Clínico Universitario San Carlos
        • Contact:
          • Principal Investigator
      • Madrid, Spain, 28905
        • Not yet recruiting
        • Hospital de Getafe
        • Contact:
          • Principal Investigator
      • Murcia, Spain, 30120
        • Not yet recruiting
        • Hospital Virgen Arrixaca de Murcia
        • Contact:
          • Principal Investigator
      • Oviedo, Spain, 330011
        • Not yet recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Principal Investigator
      • Palma, Spain, 07198
        • Not yet recruiting
        • Hospital Son Llatzer
        • Contact:
          • Principal Investigator
      • Palma de Mallorca, Spain, 07210
        • Not yet recruiting
        • Hospital Son Espases
        • Contact:
          • Principal Investigator
      • Pontevedra, Spain, 36001
        • Not yet recruiting
        • Hospital de Pontevedra
        • Contact:
          • Principal Investigator
      • Reus, Spain, 43204
        • Not yet recruiting
        • Hospital San Joan de Reus
        • Contact:
          • Principal Investigator
      • Sabadell, Spain, 08208
        • Not yet recruiting
        • Hospital Universitari Parc Tauli
        • Contact:
          • Principal Investigator
      • Sant Cugat del Vallès, Spain, 08195
        • Not yet recruiting
        • Hospital General de Catalunya
        • Contact:
          • Principal Investigator
      • Santander, Spain, 39008
        • Not yet recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
          • Principal Investigator
      • Valencia, Spain, 46014
        • Not yet recruiting
        • Hospital Universitario General de Valencia
        • Contact:
          • Principal Investigator
      • Valladolid, Spain, 47003
        • Not yet recruiting
        • Hospital Clínico de Valladolid
        • Contact:
          • Principal Investigator
      • Vigo Pontevedra, Spain, 36312
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Vigo
        • Contact:
          • Principal Investigator
  • Sweden
      • Stockholm, Sweden, 11912
        • Not yet recruiting
        • Capio St Görans sjukhus
        • Contact:
          • Principal Investigator
      • Stockholm, Sweden, 17176
        • Not yet recruiting
        • Bröstcentrum, Karolinska Universitetssjukhuset Solna
        • Contact:
          • Principal Investigator
      • Västerås, Sweden, 72335
        • Not yet recruiting
        • Department of Oncology, Västerås
        • Contact:
          • Principal Investigator
      • Örebro, Sweden, 70185
        • Not yet recruiting
        • Department of Oncology, Örebro University Hospital
        • Contact:
          • Principal Investigator
  • Switzerland
      • Baden, Switzerland, 5404
        • Not yet recruiting
        • Kantonsspital Baden
        • Contact:
          • Principal Investigator
      • Frauenfeld, Switzerland, 8500
        • Terminated
        • Spital Thurgau AG - Kantonsspital Frauenfeld
      • Fribourg, Switzerland, 1701
        • Not yet recruiting
        • Centre du sein Fribourg
        • Contact:
          • Principal Investigator
      • Genève, Switzerland, 1206
        • Not yet recruiting
        • Clinique Generale-Beaulieu / Clinique de Genolier
        • Contact:
          • Principal Investigator
      • Lausanne, Switzerland, 1011
        • Not yet recruiting
        • CHUV
        • Contact:
          • Principal Investigator
      • Sion, Switzerland, 1951
        • Not yet recruiting
        • Hôpital du Valais Sion
        • Contact:
          • Principal Investigator
      • Zürich, Switzerland, 8005
        • Not yet recruiting
        • ZIO AG
        • Contact:
          • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trastuzumab deruxtecan (T-DXd)
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.
Drug: Trastuzumab deruxtecan

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.

Other Names:
  • T-DXd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
Time Frame: Baseline up to 31 months
Baseline up to 31 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer
Time Frame: Baseline up to 31 months
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)
Time Frame: Baseline up to 31 months
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)
Time Frame: Baseline up to 31 months
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
Time Frame: Baseline up to 31 months
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
Time Frame: 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.
Baseline up to 31 months
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
Time Frame: 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).
Baseline up to 31 months
Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary
Time Frame: Baseline up to 31 months
Baseline up to 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

  • Study Director: Global Team Leader, Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-0005-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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