DESTINY Breast Respond HER2-(Ultra)Low Europe
Recruiting · NCT05945732 · Observational (researchers observe without assigning treatment) · Lead sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- Study Group 1 and Study Group 2
- 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 other specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.
Where it is running
60 locations listed.
- Aalborg Universitetshospital, Syd - Aalborg, Denmark
- ASZ Aalst - Aalst, Belgium
- Aarhus University Hospital - Aarhus N, Denmark
- Hospital Clinico Universitario de Albacete - Albacete, Spain
- Hospital de Cascais - Alcabideche, Lisboa, Portugal
- Azienda Ospedaliera di Alessandria - Alessandria, Italy
- Hospital General Universitario de Alicante - Alicante, Spain
- Hospital Universitario de La Ribera - Alzira, Spain
- ULS Amadora Sintra - Amadora, Lisboa, Portugal
- CHU Amiens Picardie - Amiens, France
- Clinique de l'Europe - Amiens, France
- Hôpital Privé d'Antony - Antony, France
- Hôpital Privé les Bonnettes - Arras, France
- Chirec Delta Hospital - Auderghem, Belgium
- Institut du Cancer Avignon Provence - Avignon, France
- Kantonsspital Baden - Baden, Switzerland
- Hospital Universitario de Cruces - Barakaldo, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Hosp. Univ. de Bellvitge - Ico Hospitalet - Duran I Reynals - Barcelona, Spain
- CH Cote Basque - Bayonne, France
- Clinique Belharra - Bayonne, France
- Chu Jean Minjoz Besancon - Besançon, France
- Hospital Universitario de Basurto - Bilbao, Spain
- Nordlandssjukhuset Bodø - Bodø, Norway
- Imeldaziekenhuis Bonheiden - Bonheiden, Belgium
- Clinique Tivoli-Ducos - Bordeaux, France
- Centre hospitalier Fleyriat - Bourg-en-Bresse, France
- ULS Braga - Braga, Portugal
- AZ Klina - Brasschaat, Belgium
- AZ Sint-Jan Brugge av - Bruges, Belgium
- CHU Brugmann - Brussels, Belgium
- Cliniques universitaires Saint-Luc - Brussels, Belgium
- Hospital Universitario de Puerto Real - Cadiz, Spain
- Centre Francois Baclesse - Caen, France
- Centre Hospitalier William Morey - Chalon-sur-Saône, France
- Pole Sante Leonard De Vinci - Chambray-lès-Tours, France
- CH Metropole Savoie - Chambéry, France
- Ospedale SS Annunziata - Chieti, Italy
- CH Cholet - Cholet, France
- Ospedale Citta' di Castello USL Umbria 1 - Città di Castello, Italy
- Centre Jean Perrin - Clermont-Ferrand, France
- Polyclinique St Côme - Compiègne, France
- Hôpital Henri Mondor - Créteil, France
- Hospital Universitario San Pedro de Alcántara - Cáceres, Spain
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Centre Léonard de Vinci - Dechy, France
- Centre Georges Francois Leclerc - Dijon, France
- Drammen Sykehus - Drammen, Norway
- Hospital General Universitario de Elche - Elche, Spain
- Ospedale San Giuseppe - Azienda USL Toscana Centro - Empoli, Italy
- Onkologikliniken Mälarsjukhuset - Eskilstuna, Sweden
- CHU Martinique - Fort de France Cedex, France
- Spital Thurgau AG - Kantonsspital Frauenfeld - Frauenfeld, Switzerland
- Centre du sein Fribourg - Fribourg, Switzerland
- CHI Frejus Saint Raphael - Fréjus, France
- Hospital de Galdakao - Galdakao, Spain
- Clinique Generale-Beaulieu / Clinique de Genolier - Geneva, Switzerland
- Hospital Clinico Universitario de Granada (PTS) - Granada, Spain
- Medizinische Universität Graz - Graz, Austria
- Medizinische Universität Graz - Graz, Austria
Showing 60 of 216 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →