Recruiting

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…

ClinicalTrials.gov IDNCT05945732

PhaseNot Applicable

Enrollment2295

SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-(Ultra)Low Expressing Breast Cancer

About this study

Interventions

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.

Primary outcomes

Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer (Baseline up to approximately 37 months)

Eligibility information

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.

Study locations

Medizinische Universität Graz, Graz, 8036 Austria
Medizinische Universität Graz, Graz, 8036 Austria
Medizinische Universität Innsbruck, Innsbruck, 6020 Austria
Klinikum Klagenfurt am Wörthersee, Klagenfurt, 9020 Austria
LKH Hochsteiermark-Leoben, Leoben, 8700 Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, 4010 Austria
Interne II, LKH Feldkirch, Rankweil, 6830 Austria
KH der Barmherzigen Brüder Salzburg, Salzburg, 5010 Austria
Uniklinikum Salzburg, Salzburg, 5020 Austria
Medical University of Vienna, Vienna, 1090 Austria

Showing 10 of 216 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.