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NCT05945732Recruiting

DESTINY Breast Respond HER2-(Ultra)Low Europe

A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2295 (estimated)
First submitted
6 Jul 2023
Start date
Oct 2023
Primary completion date
Dec 2030
Lead sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
NCT number
NCT05945732

What you commit to

  • Study type: Observational
  • Planned participants: 2295
  • From Oct 2023 to the primary completion date, Dec 2030
  • 215 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (215)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universität Graz
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GrazAustriaTerminated
Medizinische Universität Innsbruck
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InnsbruckAustriaRecruiting
Klinikum Klagenfurt am Worthersee
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KlagenfurtAustriaRecruiting
LKH Hochsteiermark-Leoben
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LeobenAustriaWithdrawn
Ordensklinikum Linz GmbH - Barmherzige Schwestern
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LinzAustriaRecruiting
Interne II, LKH Feldkirch
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RankweilAustriaActive, not recruiting
KH der Barmherzigen Brüder Salzburg
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SalzburgAustriaRecruiting
Uniklinikum Salzburg
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SalzburgAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Medizinische Universität Wien
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ViennaAustriaTerminated
Krankenhaus Hietzing
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ViennaAustriaRecruiting
Salzkammergut-Klinikum Vöcklabruck
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VöcklabruckAustriaRecruiting
Klinikum Wels-Grieskirchen GmbH
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WelsAustriaActive, not recruiting
Landesklinikum Wiener Neustadt
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Wiener NeustadtAustriaRecruiting
ASZ Aalst
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AalstBelgiumActive, not recruiting
Chirec Delta Hospital
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AuderghemBelgiumActive, not recruiting
Imeldaziekenhuis Bonheiden
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BonheidenBelgiumActive, not recruiting
AZ KLINA
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BrasschaatBelgiumActive, not recruiting
Az Sint-Jan Brugge Av
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BrugesBelgiumActive, not recruiting
Cliniques universitaires Saint-Luc
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BrusselsBelgiumActive, not recruiting
CHU Brugmann
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BrusselsBelgiumActive, not recruiting
CHU HELORA - Hôpital de la Louvière - Site Jolimont
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Haine-Saint-PaulBelgiumActive, not recruiting
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
CHU Tivoli
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La LouvièreBelgiumActive, not recruiting
Hôpital de la Citadelle
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LiègeBelgiumActive, not recruiting
CHC MontLégia
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LiègeBelgiumActive, not recruiting
CHU UCL Namur / Site Sainte Elisabeth
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NamurBelgiumActive, not recruiting
Clinique Saint Pierre Ottignies
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OttigniesBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
CHR Verviers East Belgium
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VerviersBelgiumActive, not recruiting
Kantonsspital Baden
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BadenSwitzerlandRecruiting
Spital Thurgau AG - Kantonsspital Frauenfeld
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FrauenfeldSwitzerlandTerminated
Centre du sein Fribourg
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FribourgSwitzerlandRecruiting
Clinique Generale-Beaulieu / Clinique de Genolier
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GenevaSwitzerlandRecruiting
Réseau Hospitalier Neuchâtelois (RHNe)
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La Chaux-de-FondsSwitzerlandRecruiting
Réseau du Sein Lausanne
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LausanneSwitzerlandRecruiting
CHUV
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LausanneSwitzerlandRecruiting
Kantonsspital Baselland
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LiestalSwitzerlandRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandNot yet recruiting
Hôpital du Valais - Sion
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SionSwitzerlandTerminated
ZIO AG
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ZurichSwitzerlandActive, not recruiting
Universitätsspital Zürich
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ZurichSwitzerlandRecruiting
Aalborg Universitetshospital, Syd
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AalborgDenmarkTerminated
Aarhus University Hospital
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Aarhus NDenmarkActive, not recruiting
Herlev Hospital
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HerlevDenmarkActive, not recruiting
Onkologisk og Palliativ afdeling, Nordsjællands Hospital
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HillerødDenmarkActive, not recruiting
Naestved Hospital
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NæstvedDenmarkActive, not recruiting
Sygehus Sønderjylland, Sønderborg
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SønderborgDenmarkTerminated
Hospital Clinico Universitario de Albacete
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AlbaceteSpainActive, not recruiting
Hospital General Universitario de Alicante
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AlicanteSpainNot yet recruiting
Hospital Universitario de La Ribera
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AlziraSpainActive, not recruiting
Hospital Universitario de Cruces
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BarakaldoSpainTerminated
Hosp. Univ. de Bellvitge - Ico Hospitalet - Duran I Reynals
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BarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario de Basurto
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BilbaoSpainActive, not recruiting
Hospital Universitario San Pedro de Alcántara
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CáceresSpainActive, not recruiting
Hospital Universitario de Puerto Real
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CadizSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital General Universitario de Elche
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ElcheSpainActive, not recruiting
Hospital de Galdakao
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GaldakaoSpainActive, not recruiting
Hospital Clinico Universitario de Granada (PTS)
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GranadaSpainActive, not recruiting
Hospital Universitario Médico-Quirúrgico de Jaén
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JaénSpainActive, not recruiting
Complejo Asistencial Universitario de Leon
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LeónSpainTerminated
Hospital Universitario San Pedro de Logroño
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LogroñoSpainWithdrawn
Hospital Universitario Lucus Augusti
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LugoSpainActive, not recruiting
Hospital Universitario Puerta de Hierro
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MadridSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Clínico Universitario San Carlos
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MadridSpainActive, not recruiting
Hospital MD Anderson Cancer Center
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MadridSpainActive, not recruiting
Hospital Universitario la Princesa
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MadridSpainActive, not recruiting
Hospital de Getafe
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
Hospital Virgen Arrixaca de Murcia
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MurciaSpainActive, not recruiting
Hospital Universitario Central De Asturias
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OviedoSpainActive, not recruiting
Complejo Asistencial Universitario de Palencia
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PalenciaSpainTerminated
Hospital Son Llatzer
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PalmaSpainTerminated
Hospital Son Espases
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Palma de MallorcaSpainActive, not recruiting
Hospital de Pontevedra
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PontevedraSpainActive, not recruiting
Hospital San Joan de Reus
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ReusSpainActive, not recruiting
Hospital Universitari Parc Taulí
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SabadellSpainActive, not recruiting
Complejo Asistencial Universitario de Salamanca
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SalamancaSpainTerminated
Hospital Universitario de Canarias
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San Cristóbal de La LagunaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
Hospital General De Catalunya
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Sant Cugat del VallèsSpainActive, not recruiting
Hospital Universitario General de Valencia
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ValenciaSpainActive, not recruiting
Hospital Clínico de Valladolid
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ValladolidSpainActive, not recruiting
Hospital Universitario Rio Hortega
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ValladolidSpainActive, not recruiting
Complejo Hospitalario Universitario De Vigo
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Vigo PontevedraSpainActive, not recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting
Clinique de l'Europe
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AmiensFranceActive, not recruiting
Chu Amiens Picardie
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AmiensFranceActive, not recruiting
Hopital Prive D Antony
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AntonyFranceWithdrawn
Hôpital Privé Les Bonnettes
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ArrasFranceActive, not recruiting
Institut du Cancer Avignon-Provence
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AvignonFranceActive, not recruiting
CH Côte Basque
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BayonneFranceActive, not recruiting
Clinique Belharra
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BayonneFranceWithdrawn
Chu Jean Minjoz Besancon
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BesançonFranceActive, not recruiting
Clinique Tivoli-Ducos
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BordeauxFranceActive, not recruiting
Centre hospitalier Fleyriat
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Bourg-en-BresseFranceActive, not recruiting
Centre François Baclesse
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CaenFranceActive, not recruiting
Centre Hospitalier William Morey
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Chalon-sur-SaôneFranceActive, not recruiting
CH Métropole-Savoie
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ChambéryFranceActive, not recruiting
Pole Sante Leonard De Vinci
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Chambray-lès-ToursFranceActive, not recruiting
CH Cholet
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CholetFranceActive, not recruiting
Centre Jean Perrin
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Clermont-FerrandFranceActive, not recruiting
Polyclinique St Côme
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CompiègneFranceActive, not recruiting
Hopital Henri Mondor
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CréteilFranceActive, not recruiting
Centre Léonard de Vinci
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DechyFranceActive, not recruiting
Centre Georges François Leclerc
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DijonFranceActive, not recruiting
CHU Martinique
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Fort de France CedexFranceActive, not recruiting
Chi Fréjus-Saint-Raphaël
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FréjusFranceActive, not recruiting
Groupe Hospitalier Mutualiste (GHM) de Grenoble - Institut Daniel Hollard (IDH)
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GrenobleFranceActive, not recruiting
Polyclinique de Blois
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La Chaussée-Saint-VictorFranceWithdrawn
La Tronche - CHU Grenoble
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La TroncheFranceActive, not recruiting
Centre de Cancérologie de la Sarthe
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Le MansFranceActive, not recruiting
Centre Hospitalier Emile Roux
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Le Puy-en-VelayFranceActive, not recruiting
Hôpital Franco-Britannique Cognac Jay
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Levallois-PerretFranceActive, not recruiting
Centre Oscar Lambret
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LilleFranceActive, not recruiting
CHU Lille
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LilleFranceActive, not recruiting
Hôpital Privé Le Bois
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LilleFranceActive, not recruiting
CHU de Limoges
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LimogesFranceActive, not recruiting
Hospices Civils de Lyon
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LyonFranceActive, not recruiting
Hôpital Jean Mermoz
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LyonFranceActive, not recruiting
Hôpital-Clinique Claude Bernard
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MetzFranceWithdrawn
GH Havre
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MontivilliersFranceActive, not recruiting
Clinique Clementville
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MontpellierFranceActive, not recruiting
Hôpital Américain de Paris
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Neuilly-sur-SeineFranceActive, not recruiting
Groupe Hospitalier privé Ambroise Pare Hartmann
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Neuilly-sur-SeineFranceActive, not recruiting
Centre Antoine Lacassagne
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NiceFranceActive, not recruiting
Centre médical Oncogard
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NîmesFranceActive, not recruiting
Centre Hospitalier de Niort
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NiortFranceActive, not recruiting
Hôpital Européen Georges Pompidou
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ParisFranceActive, not recruiting
Hopital Saint Joseph
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ParisFranceActive, not recruiting
Groupement Hospitalier Diaconesses Croix Saint Simon
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ParisFranceActive, not recruiting
Institut Curie
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ParisFranceActive, not recruiting
Centre Hospitalier de Pau
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PauFranceActive, not recruiting
CHU Poitiers
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PoitiersFranceActive, not recruiting
Institut Godinot
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ReimsFranceActive, not recruiting
Polyclinique Courlancy
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ReimsFranceWithdrawn
Centre Eugène Marquis
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RennesFranceActive, not recruiting
Clinique Saint-Hilaire
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RouenFranceWithdrawn
Clinique Mathilde
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RouenFranceActive, not recruiting
Saint Cloud -Rene Huguenin Institut Curie
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Saint-CloudFranceWithdrawn
CHU Réunion Site Sud
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Saint-PaulFranceActive, not recruiting
Institut De Cancerologie Paris Nord
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SarcellesFranceActive, not recruiting
Centre Hospitalier de Sens
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Sens CédexFranceActive, not recruiting
Hopital Foch
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SuresnesFranceActive, not recruiting
CHR Metz Thionville
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ThionvilleFranceActive, not recruiting
Hia Sainte Anne
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ToulonFranceActive, not recruiting
Centre Hospitalier de Troyes
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TroyesFranceWithdrawn
Hôpital Privé Drôme Ardèche
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ValenceFranceActive, not recruiting
Nouvelle Clinique Des Dentellières
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ValenciennesFranceActive, not recruiting
Institut de Cancérologie de Lorraine
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Vandœuvre-lès-NancyFranceWithdrawn
Centre d'Oncologie Saint-Yves
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VannesFranceActive, not recruiting
Médipôle Hôpital Mutualiste
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VilleurbanneFranceActive, not recruiting
Azienda Ospedaliera di Alessandria
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AlessandriaItalyActive, not recruiting
Ospedale Ss Annunziata
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ChietiItalyActive, not recruiting
Ospedale Citta' di Castello USL Umbria 1
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Città di CastelloItalyTerminated
Ospedale San Giuseppe - Azienda USL Toscana Centro
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EmpoliItalyActive, not recruiting
ASL Lecce - Ospedale "Vito Fazzi"
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LecceItalyWithdrawn
ASST Lecco - PO "Alessandro Manzoni"
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LeccoItalyActive, not recruiting
AULSS 9 Scaligera Ospedale Mater Salutis
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LegnagoItalyActive, not recruiting
ASST Ovest Milanese - Ospedale di Legnano
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LegnanoItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS
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MeldolaItalyActive, not recruiting
AOU di Modena
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ModenaItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
AOU Federico II
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NaplesItalyActive, not recruiting
AOU Maggiore della Carità di Novara
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NovaraItalyActive, not recruiting
IOV - Istituto Oncologico Veneto IRCCS
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PadovaItalyActive, not recruiting
ARNAS Ospedale Civico e Benfratelli
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PalermoItalyActive, not recruiting
La Maddalena S.p.A.
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PalermoItalyTerminated
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
AOU Pisana - Stabilimento Santa Chiara
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PisaItalyActive, not recruiting
AO Regionale San Carlo
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PotenzaItalyActive, not recruiting
Ospedale Generale Provinciale di Macerata
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Province of MacerataItalyActive, not recruiting
GOM "BMM" - Presidio Ospedaliero Morelli
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Reggio CalabriaItalyActive, not recruiting
Azienda USL IRCCS di Reggio Emilia
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Reggio EmiliaItalyActive, not recruiting
AO San Giovanni Addolorata
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RomaItalyActive, not recruiting
ASL RM 2 Ospedale Pertini
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RomaItalyActive, not recruiting
AOU "San Giovanni di Dio e Ruggi d'Aragona"
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SalernoItalyActive, not recruiting
IRCCS Ospedale Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyActive, not recruiting
AOU Sassari - Ospedale Civile SS. Annunziata
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SassariItalyActive, not recruiting
Ospedale San Vincenzo
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TaorminaItalyActive, not recruiting
AOU Città della Salute e della Scienza di Torino - Ospedale Molinette
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TorinoItalyActive, not recruiting
AO Ordine Mauriziano
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TorinoItalyActive, not recruiting
AULSS n. 2 Marca trevigiana - Ospedale "Cà Foncello"
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TrevisoItalyActive, not recruiting
ASUFC Udine - Santa Maria della Misericordia
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UdineItalyActive, not recruiting
Asst Sette Laghi Ospedale di Circolo e Fondazione Macchi
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VareseItalyActive, not recruiting
Nordlandssjukhuset Bodø
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BodøNorwayRecruiting
Drammen Sykehus
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DrammenNorwayRecruiting
Sørlandet sykehus / Kristiansand Hospital
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KristiansandNorwayActive, not recruiting
Sykehuset Telemark
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SkienNorwayRecruiting
Universitetssjukhuset Nord-Norge
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TromsøNorwayActive, not recruiting
Hospital de Cascais
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Alcabideche, LisboaPortugalWithdrawn
ULS Amadora Sintra
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Amadora, LisboaPortugalWithdrawn
ULS Braga
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BragaPortugalWithdrawn
IPO Lisboa
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LisbonPortugalWithdrawn
Hospital da Luz Lisboa
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LisbonPortugalWithdrawn
Dra. Berta Sousa
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LisbonPortugalWithdrawn
ULS Santa Maria
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LisbonPortugalWithdrawn
ULS Loures-Odivelas - Hospital Beatriz Ângelo
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LouresPortugalWithdrawn
ULS Santo António
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PortoPortugalWithdrawn
Instituto Português de Oncologia do Porto Francisco Gentil
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PortoPortugalWithdrawn
ULS Matosinhos
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PortoPortugalWithdrawn
ULS Trás-os-Montes e Alto Douro
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Vila RealPortugalWithdrawn
Onkologikliniken Mälarsjukhuset
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EskilstunaSwedenRecruiting
Gävle Hospital
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GävleSwedenRecruiting
Ryhov County Hospital
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JönköpingSwedenActive, not recruiting
Department of Oncology, Örebro University Hospital
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ÖrebroSwedenRecruiting
Bröstcentrum, Karolinska Universitetssjukhuset Solna
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StockholmSwedenActive, not recruiting
Capio St Görans sjukhus
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StockholmSwedenActive, not recruiting
Onkologkliniken Sundsvalls Sjukhus
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SundsvallSwedenWithdrawn
Cancercentrum, Norrlands Universitetssjukhus
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UmeåSwedenRecruiting
Department of Oncology, Västerås
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VästeråsSwedenRecruiting

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