Status:
RECRUITING
DESTINY Breast Respond HER2-low Europe
Lead Sponsor:
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Conditions:
Unresectable Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 metast...
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 r...
Eligibility Criteria
Inclusion Criteria:
- Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
- 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
- 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
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
1155 Patients enrolled
Trial Details
Trial ID
NCT05945732
Start Date
October 24 2023
End Date
September 1 2028
Last Update
February 12 2026
Active Locations (211)
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1
Medizinische Universität Graz
Graz, Austria, 8036
2
Medizinische Universität Graz
Graz, Austria, 8036
3
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
4
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020