Actively Recruiting
A Prospective, Non-interventional Study With Trastuzumab Deruxtecan For Patients With HER2-low Unresectable andor Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy
Led by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company · Updated on 2026-02-12
1155
Participants Needed
211
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the use of trastuzumab deruxtecan T-DXd in adults with HER2-low unresectable or metastatic breast cancer who have previously received chemotherapy in the metastatic setting or experienced disease recurrence within 6 months after adjuvant chemotherapy. The study will collect information on patient characteristics, how treatments are used, tolerability, management of side effects, and patient experiences with T-DXd, as well as data on conventional chemotherapy treatments in a registry. Participants will receive T-DXd or conventional chemotherapy as chosen by their doctors according to approved guidelines in routine clinical practice. No study drug is given by the research team since this is a non-interventional study. The conventional chemotherapy group will be analyzed separately to better understand treatment patterns and outcomes. During the study, researchers will gather data for up to 31 months, monitoring real-world time to next treatment, treatment patterns, safety events, use of treatments to manage side effects, and patient-reported outcomes including tolerability and quality of life. They will also track occurrences of nausea and vomiting through patient diaries. This information will help evaluate treatment use and patient experiences outside of clinical trial settings.
CONDITIONS
Brief Title
DESTINY Breast Respond HER2-low Europe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 years or older with confirmed unresectable and/or metastatic breast cancer
- Documented HER2-low status (IHC1+ or IHC2+/ISH-)
- Received prior chemotherapy in metastatic setting or had disease recurrence within 6 months after adjuvant chemotherapy
- Decision made to start trastuzumab deruxtecan or conventional chemotherapy per physician choice
- Signed informed consent to participate in the study
You will not qualify if you...
- Pregnancy or breastfeeding
- Currently participating in or previously participated in a blinded interventional clinical study
- No other specific exclusion criteria; treatment follows approved indications
Research Team
C
Contact for Clinical Trial Information
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