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Clinical Trials in Italy / NCT05945732
Recruiting Observational

DESTINY Breast Respond HER2-(Ultra)Low Europe

NCT05945732 · tracked via the Priya Life Science Italy tracker
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Phase
Observational
Started
2023-10-24
Last updated
2026-08-19

Condition(s) studied

Unresectable Breast CancerMetastatic Breast CancerHER2-low Expressing Breast CancerHER2-(Ultra)Low Expressing Breast Cancer

Investigational drug(s) / intervention(s)

Trastuzumab deruxtecan →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (216)

FacilityCityRegionStatus
Medizinische Universität Graz Graz Austria Terminated
Medizinische Universität Graz Graz Austria Recruiting
Medizinische Universität Innsbruck Innsbruck Austria Recruiting
Klinikum Klagenfurt am Wörthersee Klagenfurt Austria Recruiting
LKH Hochsteiermark-Leoben Leoben Austria Withdrawn
Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Austria Recruiting
Interne II, LKH Feldkirch Rankweil Austria Active Not Recruiting
KH der Barmherzigen Brüder Salzburg Salzburg Austria Recruiting
Uniklinikum Salzburg Salzburg Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
Medizinische Universität Wien Vienna Austria Terminated
Krankenhaus Hietzing Vienna Austria Recruiting
Salzkammergut Klinikum Vöcklabruck Vöcklabruck Austria Recruiting
Klinikum Wels-Grieskirchen GmbH Wels Austria Active Not Recruiting
Landesklinikum Wiener Neustadt Wiener Neustadt Austria Recruiting
ASZ Aalst Aalst Belgium Active Not Recruiting
Chirec Delta Hospital Auderghem Belgium Active Not Recruiting
Imeldaziekenhuis Bonheiden Bonheiden Belgium Active Not Recruiting
AZ Klina Brasschaat Belgium Active Not Recruiting
AZ Sint-Jan Brugge av Bruges Belgium Active Not Recruiting
CHU Brugmann Brussels Belgium Active Not Recruiting
Cliniques universitaires Saint-Luc Brussels Belgium Active Not Recruiting
Chu Helora- Hôpital de La Louvière- site Jolimont Haine-Saint-Paul Belgium Active Not Recruiting
Jessa Ziekenhuis Hasselt Belgium Active Not Recruiting
CHU Tivoli La Louvière Belgium Active Not Recruiting
CHC MontLegia Liège Belgium Active Not Recruiting
Hôpital de la Citadelle Liège Belgium Active Not Recruiting
CHU UCL Namur/Site Sainte Elisabeth Namur Belgium Active Not Recruiting
Clinique Saint Pierre Ottignies Ottignies Belgium Active Not Recruiting
VITAZ Sint-Niklaas Belgium Active Not Recruiting
CHR Verviers East Belgium Verviers Belgium Active Not Recruiting
Aalborg Universitetshospital, Syd Aalborg Denmark Terminated
Aarhus University Hospital Aarhus N Denmark Active Not Recruiting
Herlev Hospital Herlev Denmark Active Not Recruiting
Onkologisk og Palliativ afdeling, Nordsjællands Hospital Hillerød Denmark Active Not Recruiting
Naestved Hospital Næstved Denmark Active Not Recruiting
Sygehus Sønderjylland, Sønderborg Sønderborg Denmark Terminated
CHU Amiens Picardie Amiens France Active Not Recruiting
Clinique de l'Europe Amiens France Active Not Recruiting
Hôpital Privé d'Antony Antony France Withdrawn

+ 176 more sites — see the full list on the official registry below.

On this site

📄 Enhertu (trastuzumab deruxtecan) drug profile →

More Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company trials in Italy

Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia Active, not recruiting
A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY) Active, not recruiting
A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia Recruiting

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A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) Active, not recruiting
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05945732 on ClinicalTrials.gov ↗ ← All trials in Italy