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NCT05945732Recruiting

DESTINY Breast Respond HER2-(Ultra)Low Europe

Official recordSimplified version

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. 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.

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland, France, Italy, Austria, Belgium, Denmark, Norway, Portugal, Spain, Sweden
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company(Industry)
Protocol no.
DS8201-0005-NIS-MA
Conditions
Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer
Interventions
Drug

Treatments studied

  • Trastuzumab deruxtecan

Locations · 26

  • Baden, SwitzerlandKantonsspital BadenRecruiting at this site
  • Fribourg, SwitzerlandCentre du sein FribourgRecruiting at this site
  • Geneva, SwitzerlandClinique Generale-Beaulieu / Clinique de GenolierRecruiting at this site
  • La Chaux-de-Fonds, SwitzerlandRéseau Hospitalier Neuchâtelois (RHNe)Recruiting at this site
  • Lausanne, SwitzerlandRéseau du Sein LausanneRecruiting at this site
  • Lausanne, SwitzerlandCHUVRecruiting at this site
  • Liestal, SwitzerlandKantonsspital BasellandRecruiting at this site
  • Zurich, SwitzerlandUniversitätsspital ZürichRecruiting at this site
  • Graz, AustriaMedizinische Universität GrazRecruiting at this site
  • Innsbruck, AustriaMedizinische Universität InnsbruckRecruiting at this site
  • Klagenfurt, AustriaKlinikum Klagenfurt am WörtherseeRecruiting at this site
  • Linz, AustriaOrdensklinikum Linz GmbH Barmherzige SchwesternRecruiting at this site
  • Salzburg, AustriaKH der Barmherzigen Brüder SalzburgRecruiting at this site
  • Salzburg, AustriaUniklinikum SalzburgRecruiting at this site
  • Vienna, AustriaMedical University of ViennaRecruiting at this site
  • Vienna, AustriaKrankenhaus HietzingRecruiting at this site
  • Vöcklabruck, AustriaSalzkammergut Klinikum VöcklabruckRecruiting at this site
  • Wiener Neustadt, AustriaLandesklinikum Wiener NeustadtRecruiting at this site
  • Bodø, NorwayNordlandssjukhuset BodøRecruiting at this site
  • Drammen, NorwayDrammen SykehusRecruiting at this site
  • Skien, NorwaySykehuset TelemarkRecruiting at this site
  • Eskilstuna, SwedenOnkologikliniken MälarsjukhusetRecruiting at this site
  • Gävle, SwedenGävle HospitalRecruiting at this site
  • Örebro, SwedenDepartment of Oncology, Örebro University HospitalRecruiting at this site
  • Umeå, SwedenCancercentrum, Norrlands UniversitetssjukhusRecruiting at this site
  • Västerås, SwedenDepartment of Oncology, VästeråsRecruiting at this site

In total, worldwide, 26 of the 216 sites listed in the registry are recruiting; the other 190 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: August 19, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.