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Tests whether adding an antibody-drug conjugate after surgery reduces recurrence in triple-negative breast cancer with residual disease.
ASCENT-05 / OptimICE-RD compares postoperative sacituzumab govitecan plus pembrolizumab with physician choice of pembrolizumab with or without capecitabine for TNBC with residual invasive disease after neoadjuvant treatment. The primary endpoint is invasive disease-free survival. ClinicalTrials.gov record last updated 2026-09-09: recruiting. Enrollment is planned at 1514 participants. Primary completion is estimated at 2027-06. 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 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 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 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 CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer.
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), Early triple-negative breast cancer.
Shares KEYNOTE-522, Pathologic complete response (pCR), UCSF Helen Diller Family Comprehensive Cancer Center, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares TROP2, Early triple-negative breast cancer, Topoisomerase-I inhibitors (and ADC payloads), Capecitabine.
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