DESTINY Breast Respond HER2-low Europe

Metastatic Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945732
• Other study ID #: DS8201-0005-NIS-MA
• Status: Recruiting
• Start date: October 24, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: March 2024
• Source: Daiichi Sankyo
• Contact: Contact for Clinical Trial Information
• Phone: 908-992-6400
• Email: CTRinfo[@]dsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: September 1, 2028
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Unresectable Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Innsbruck	Innsbruck
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	Krankenhaus Hietzing	Wien
Austria	Medical University of Vienna	Wien
Austria	Medizinische Universität Wien	Wien
Austria	Landesklinikum Wiener Neustadt	Wiener Neustadt
Belgium	ASZ Aalst	Aalst
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	CHU Tivoli	La Louviere
Belgium	Hôpital de la Citadelle	Liege
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Belgium	Clinique Saint Pierre Ottignies	Ottignies
Belgium	VITAZ	Sint-Niklaas
Belgium	CHR Verviers East Belgium	Verviers
Denmark	Aalborg Universitetshospital, Syd	Aalborg
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Sygehus Sønderjylland, Sønderborg	Sønderborg
France	CHU Amiens Picardie	Amiens
France	Clinique de l'Europe	Amiens
France	Institut du Cancer Avignon Provence	Avignon
France	CH Cote Basque	Bayonne
France	Clinique Belharra	Bayonne
France	Chu Jean Minjoz Besancon	Besançon
France	Clinique Tivoli-Ducos	Bordeaux
France	Centre hospitalier Fleyriat	Bourg-en-Bresse
France	Centre Francois Baclesse	Caen
France	Centre Hospitalier William Morey	Chalon-sur-Saône
France	CH Metropole Savoie	Chambéry
France	Pole Sante Leonard De Vinci	Chambray-lès-Tours
France	CH Cholet	Cholet
France	Centre Jean Perrin	Clermont-Ferrand
France	Polyclinique St Côme	Compiègne
France	Hôpital Henri Mondor	Créteil
France	Centre Léonard de Vinci	Dechy
France	Centre Georges Francois Leclerc	Dijon
France	CHU Martinique	Fort De France Cedex
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	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 Médical ONCOGARD	NÎMES Cedex 9
France	Centre Hospitalier de Niort	Niort
France	Groupement Hospitalier Diaconesses Croix Saint Simon	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hôpital Saint Joseph	Paris
France	Institut Curie	Paris
France	CHU Poitiers	Poitiers
France	Institut Godinot	Reims
France	Polyclinique Courlancy	Reims
France	Clinique Mathilde	Rouen
France	Clinique Saint Hilaire	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
Italy	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	ASST Lecco - PO "Alessandro Manzoni"	Lecco
Italy	AULSS 9 Scaligera - Ospedale Mater Salutis	Legnago
Italy	Ospedale Generale Provinciale di Macerata	Macerata
Italy	Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS	Meldola
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	ARNAS Ospedale Civico e Benfratelli	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	AO Regionale San Carlo	Potenza
Italy	AO San Giovanni Addolorata	Roma
Italy	ASL RM 2 Ospedale Pertini	Roma
Italy	AOU "San Giovanni di Dio e Ruggi d'Aragona"	Salerno
Italy	Ospedale San Vincenzo	Taormina
Italy	AO Ordine Mauriziano	Torino
Italy	AOU Città della Salute e della Scienza di Torino - Ospedale Molinette	Torino
Italy	ASUFC Udine - Santa Maria della Misericordia	Udine
Italy	ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "	Varese
Norway	Universitetssjukhuset Nord-Norge	Tromsø
Spain	Hospital Clinico Universitario de Albacete	Albacete
Spain	Hospital Universitario de La Ribera	Alzira
Spain	Hospital Universitario de Basurto	Bilbao
Spain	Hospital Universitario San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario de Puerto Real	Cádiz
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Clinico Universitario de Granada (PTS)	Granada
Spain	Hospital Universitario de Canarias	La Laguna
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Clínico Universitario San Carlos	Madrid
Spain	Hospital de Getafe	Madrid
Spain	Hospital MD Anderson Cancer Center	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Virgen Arrixaca de Murcia	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Llatzer	Palma
Spain	Hospital Son Espases	Palma de Mallorca
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	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Universitario General de Valencia	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Complejo Hospitalario Universitario De Vigo	Vigo Pontevedra
Sweden	Department of Oncology, Örebro University Hospital	Örebro
Sweden	Bröstcentrum, Karolinska Universitetssjukhuset Solna	Stockholm
Sweden	Capio St Görans sjukhus	Stockholm
Sweden	Department of Oncology, Västerås	Västerås
Switzerland	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	CHUV	Lausanne
Switzerland	Hôpital du Valais Sion	Sion
Switzerland	ZIO AG	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Italy,  Norway,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type of Treatment Patterns in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer		Baseline up to 31 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient's Global Impression of Treatment Tolerability (PGI-TT) in Participants With HER2-low Expressing 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.	Baseline up to 31 months
Secondary	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	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
Secondary	Number of Participants Reporting Nausea and Vomiting as Assessed by a Patient Diary		Baseline up to 31 months