MedTrace Logo

DESTINY Breast Respond HER2-(Ultra)Low Europe

NCT05945732 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2295

Last updated 2026-08-19

No results posted yet for this 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.

Conditions

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

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.

Sponsors & Collaborators

  • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

    lead INDUSTRY

Principal Investigators

  • Global Team Leader · Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-24
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Italy
  • Norway
  • Portugal
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05945732 on ClinicalTrials.gov