Trials / Recruiting
RecruitingNCT05945732
DESTINY Breast Respond HER2-low Europe
A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-low Europe)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,155 (estimated)
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-10-24
- Primary completion
- 2028-09-01
- Completion
- 2028-09-01
- First posted
- 2023-07-14
- Last updated
- 2026-02-12
Locations
211 sites across 10 countries: Austria, Belgium, Denmark, France, Italy, Norway, Portugal, Spain, Sweden, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05945732. Inclusion in this directory is not an endorsement.