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Taking people in AustriaNo phase

Follows patients with HER2-low breast cancer treated with trastuzumab deruxtecan

Observes adults with advanced HER2-low breast cancer receiving trastuzumab deruxtecan, a targeted drug.

Plain-language title generated from the registry record
Registry title: DESTINY Breast Respond HER2-(Ultra)Low Europe

Key facts

Where
Graz, Innsbruck, Klagenfurt, Leoben, Linz, Rankweil, Salzburg, Vienna, Vöcklabruck, Wels, and Wiener Neustadt, AustriaSee the 14 sites

Where in Austria

  • Medizinische Universität GrazGraz, AustriaNo longer taking part
  • Medizinische Universität InnsbruckInnsbruck, AustriaTaking people
  • Klinikum Klagenfurt am WortherseeKlagenfurt, AustriaTaking people
  • LKH Hochsteiermark-LeobenLeoben, AustriaNo longer taking part
  • Ordensklinikum Linz GmbH - Barmherzige SchwesternLinz, AustriaTaking people
  • Interne II, LKH FeldkirchRankweil, AustriaNo longer taking part
  • KH der Barmherzigen Brüder SalzburgSalzburg, AustriaTaking people
  • Uniklinikum SalzburgSalzburg, AustriaTaking people
  • Krankenhaus HietzingVienna, AustriaTaking people
  • Medical University of ViennaVienna, AustriaTaking people
  • Medizinische Universität WienVienna, AustriaNo longer taking part
  • Salzkammergut-Klinikum VöcklabruckVöcklabruck, AustriaTaking people
  • Klinikum Wels-Grieskirchen GmbHWels, AustriaNo longer taking part
  • Landesklinikum Wiener NeustadtWiener Neustadt, AustriaTaking people

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Trial details

Who runs it
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Trial code
NCT05945732
Record updated
19 August 2026
Original description
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.Read full original descriptionShow less

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)

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: 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: 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.

ClinicalTrials.gov NCT05945732