Study identifier:D9673C00007
ClinicalTrials.gov identifier:NCT04739761
EudraCT identifier:2020-005048-46
CTIS identifier:2024-510588-53-00
An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis with Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)
Breast Cancer
Phase 3
No
Trastuzumab Deruxtecan
All
506
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
Daiichi Sankyo
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).
Approximately 500 eligible participants will be enrolled into 1 of 2 cohorts (250 participants in each cohort) according to the presence or absence of BMs at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline. After study intervention discontinuation, all participants will undergo an end-of-treatment visit (within 7 days of discontinuation) and will be followed up for safety assessments 40 (+ up to 7) days after the discontinuation of all study intervention. All participants will be followed up for survival status and duration of treatment on subsequent therapies after intervention discontinuation every 3 months (± 14 days) from the date of the safety follow-up until death, withdrawal of consent, or the end of the study, as per defined in the protocol.
Location
Location
Napoli, Italy, 80131
Location
München, Germany, 80336
Location
Frankfurt, Germany, 60389
Location
Dresden, Germany, 1307
Location
Hamburg, Germany, 20246
Location
Essen, Germany, 45136
Location
ANCONA, Italy, 60122
Location
Prato, Italy, 59100
Arms | Assigned Interventions |
---|---|
Experimental: Trastuzumab Deruxtecan Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. | Drug: Trastuzumab Deruxtecan Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution. Other Name: fam-trastuzumab deruxtecan-nxki |
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