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Tests whether an experimental drug, with or without immunotherapy, helps prevent recurrence after residual triple-negative breast cancer is removed at surgery.
TROPION-Breast03 compares datopotamab deruxtecan plus durvalumab, datopotamab deruxtecan alone, and investigator choice of capecitabine, pembrolizumab or both after surgery for stage I to III TNBC with residual invasive disease following neoadjuvant treatment. The registered primary iDFS comparison is the datopotamab deruxtecan plus durvalumab arm against investigator choice. ClinicalTrials.gov record last updated 2026-06-15: active not recruiting. Enrollment is actual at 1174 participants. Primary completion is estimated at 2027-09-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Datopotamab deruxtecan, Daiichi Sankyo, TROP2, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype, ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Datopotamab deruxtecan, Daiichi Sankyo, TROP2, Durvalumab.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares Datopotamab deruxtecan, TROP2, Durvalumab, Topoisomerase-I inhibitors (and ADC payloads).
Shares Datopotamab deruxtecan, TROP2, Durvalumab, Triple-negative breast cancer trials open today (registry snapshot and UK sites).
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