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Taking people in SwitzerlandNo 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.

Key facts

Who runs it
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Where
Baden, Frauenfeld, Fribourg, Geneva, La Chaux-de-Fonds, Lausanne, Liestal, Sankt Gallen, Sion, and Zurich, SwitzerlandSee the 12 sitesAlso in 9 other countries, 203 sites
Trial code
Registry title
DESTINY Breast Respond HER2-(Ultra)Low Europe
Status
Recruiting
People taking part
2,295 people, planned
Started
24 Oct 2023
Expected to end
31 Dec 2030
Type of study
Observational, 2 groups
Treatments tested
  • Trastuzumab deruxtecan
Record updated
19 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with breast cancer that cannot be removed by surgery or has spread, and that has low or ultralow HER2. They start trastuzumab deruxtecan (T-DXd) or standard chemotherapy, as their doctor chooses.

Age
18 years or older
Sex
All sexes
Disease stage
Breast cancer that cannot be removed by surgery and/or has spread (metastatic), confirmed by tissue or cell tests.
Earlier treatment
Group 1: chemotherapy for metastatic disease, or the cancer came back during or within 6 months of finishing chemotherapy given after surgery. Group 2: at least one endocrine therapy for metastatic disease, and no chemotherapy for metastatic disease.
Biomarker or test result
Group 1: documented HER2-low (IHC1+, or IHC2+/ISH-). Group 2: documented HR-positive, and HER2-low (IHC1+ or IHC2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining [IHC > 0 to <1+]).

Main reasons for not taking part

  • Pregnancy or breastfeeding
  • Taking part now, or in the past, in a study that is still blinded

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Switzerland

Also in 9 other countries, 203 sites

  • Kantonsspital BadenBaden, SwitzerlandContact: Principal InvestigatorTaking people
  • Spital Thurgau AG - Kantonsspital FrauenfeldFrauenfeld, SwitzerlandNo longer taking part
  • Centre du sein FribourgFribourg, SwitzerlandContact: Principal InvestigatorTaking people
  • Clinique Generale-Beaulieu / Clinique de GenolierGeneva, SwitzerlandContact: Principal InvestigatorTaking people
  • Réseau Hospitalier Neuchâtelois (RHNe)La Chaux-de-Fonds, SwitzerlandContact: Principal InvestigatorTaking people
  • CHUVLausanne, SwitzerlandContact: Principal InvestigatorTaking people
  • Réseau du Sein LausanneLausanne, SwitzerlandContact: Principal InvestigatorTaking people
  • Kantonsspital BasellandLiestal, SwitzerlandContact: Principal InvestigatorTaking people
  • Kantonsspital St. GallenSankt Gallen, SwitzerlandContact: Principal InvestigatorNot yet recruiting
  • Hôpital du Valais - SionSion, SwitzerlandNo longer taking part
  • Universitätsspital ZürichZurich, SwitzerlandContact: Principal InvestigatorTaking people
  • ZIO AGZurich, SwitzerlandNo longer taking part

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Study Group 1

    Adult participants with 2L+ HER2-low expressing unresectable and/or metastatic breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. In addition, patients with HER2-low breast cancer treated with conventional chemotherapy will be enrolled. The participants on conventional chemotherapy will be analyzed as exploratory only.

    Treatment: Trastuzumab deruxtecan

  • Study Group 2

    Adult participants in the first-line setting with hormone receptor (HR) positive, HER2-low or HER2-(ultra)low breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment and have not received prior chemotherapy for advanced metastatic breast cancer.

    Treatment: Trastuzumab deruxtecan

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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)
Plain-language title
Follows patients with HER2-low breast cancer treated with trastuzumab deruxtecanGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 August 2026