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DESTINY Breast Respond HER2-low Europe
RECRUITINGSponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Actively Recruiting
SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Started2023-10-24
Est. completion2028-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05945732
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions5
Breast CancerCancerHER2-low Expressing Breast CancerMetastatic Breast CancerUnresectable Breast Cancer
Interventions1
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Actively Recruiting
SponsorDaiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Started2023-10-24
Est. completion2028-09-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05945732