Life sciences · Observational Study
ClinicalTrials.gov · October 16, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07092254). This is a study registration, not published results. Lead sponsor: Daiichi Sankyo. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 760 participants (ESTIMATED). Conditions: Triple Negative Breast Cancer. Interventions: DRUG: No drug. Primary outcome measures: Treatment sequencing before the diagnosis of advanced, metastatic TNBC (i.e., all treatments received for early TNBC if initially diagnosed with earlier-stage disease) , From date of initial diagnosis of early TNBC (if applicable) until diagnosis date of advanced, metastatic TNBC, up to approximately 15 months; Treatment sequencing on or after the diagnosis date for advanced, metastatic TNBC , From date of initial diagnosis of advanced, metastatic TNBC until end of follow-up, up to approximately 15 months; Real-world disease-free interval (rwDFI) , From the completion of treatment with curative intent (either date of breast tumor surgery or date of last dose of systemic therapy (whichever occurred last) and the first local or distant disease recurrence date, up to approximately 15 months; Clinician-defined real-world progression-free survival (rwPFS) , From the start of each line of therapy until end of follow up, up to approximately 15 months; Overall survival , From the start of each line of therapy until end of follow-up, up to approximately 15 months; Occurrence of clinical events of interest , From the start of each line of therapy until end of follow-up, up to approximately 15 months. Brief summary: This transnational noninterventional study aims to gather real-world evidence on locally recurrent inoperable (hereafter referred to as advanced) or metastatic TNBC (a/m TNBC) biomarker testing, treatment patterns by line of therapy, and outcomes to contextualize findings of TROPION-Breast02 and TROPION-Breast05 in selected settings outside the United States (US), including Canada, the United Kingdom (UK), France, and Spain.