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TROPION-Breast03 is the Dato-DXd counterpart to ASCENT-05: an ADC, with or without immunotherapy, for triple-negative patients with leftover cancer at surgery.
TROPION-Breast03, trial NCT05629585 sponsored by AstraZeneca and Daiichi Sankyo, is the datopotamab deruxtecan counterpart to ASCENT-05: an antibody-drug conjugate, with or without immunotherapy, for patients with stage I to III triple-negative breast cancer left with residual invasive disease after neoadjuvant therapy. It is a three-arm phase 3 of 1,075 patients randomised two to one to two to datopotamab deruxtecan for eight cycles plus durvalumab for nine, datopotamab deruxtecan alone, or investigator's choice of capecitabine, pembrolizumab or both, with invasive disease-free survival as the primary endpoint and estimated primary completion on 20 September 2027. It is ongoing with no results, and whether an ADC after residual disease improves on the KATHERINE-style switch strategy in TNBC is the question it will answer.
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 Datopotamab deruxtecan, Daiichi Sankyo, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem, Durvalumab.
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 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, Daiichi Sankyo, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares Datopotamab deruxtecan, Daiichi Sankyo, Durvalumab, Triple-negative breast cancer trials open today (registry snapshot and UK sites).