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NCT06081244 · ClinicalTrials.gov record · last posted 2026-08-03

NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

Study acronym: ADAPT-TN-III
StatusRecruiting
PhasePhase 3
Started2024-10-10
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from the ClinicalTrials.gov record
TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.

Protocol amendment history 1 change detected by DataLookout

2026-08-09
notable
Sponsor changed: West German Study Group → Women's Cancer Study Group GmbH
WasWest German Study Group
NowWomen's Cancer Study Group GmbH
Trial Details
NCT Number NCT06081244
Lead Sponsor West German Study Group
Collaborators: Merck Sharp & Dohme LLC, Gilead Sciences
Conditions Triple Negative Breast Cancer
Enrollment 348 participants
Start Date 2024-10-10
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-03