Trial intelligence / Profile preview

Phase III study of datopotamab deruxtecan with or without durvalumab versus chemotherapy plus pembrolizumab in PD-L1 positive metastatic or inoperable recurrent triple-negative breast cancer

2023-503675-24-00Phase 3Authorised

Sponsor
AstraZeneca
Start
Jan 2025
Modality
PD-1/PD-L1 Inhibitors → Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Countries
23
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Overview

Phase 3, randomised, open-label trial in triple-negative breast cancer (TNBC) comparing Datopotamab deruxtecan, Datopotamab deruxtecan + durvalumab and Investigator's choice chemotherapy + pembrolizumab (3 arms). Primary endpoint: Progression-free survival. Planned start Jan 2025; status: authorised.

02

Drugs

datopotamab deruxtecandurvalumabpembrolizumab
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Conditions

triple-negative breast cancer (TNBC)

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