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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05629585). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1174 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: Dato-DXd; DRUG: Durvalumab; DRUG: Capecitabine; DRUG: Pembrolizumab. Primary outcome measures: Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT , From randomisation to date of the event, up to 57 months from first subject in. Brief summary: This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.