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)
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
1,155 participants
Oct 24, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria2
- 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.
Interventions
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.
Locations(211)
View Full Details on ClinicalTrials.gov
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NCT05945732