TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer

Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder identification tools is warranted. This phase II trial aims to identify a precision TNBC population suitable for de-escalated neoadjuvant therapy with sacituzumab govitecan plus tislelizumab, based on differential Trop-2 expression (±) and PD-L1 status (CPS \>10% vs. \<10%). Primary endpoints include pCR rate and safety; exploratory biomarker analyses will assess mechanisms of response/resistance

NCT Number	NCT07271992
Lead Sponsor	First Hospital of China Medical University Collaborators: Liaoning Cancer Hospital & Institute
Conditions	TNBC, Triple Negative Breast Cancer
Enrollment	30 participants
Start Date	2025-12-15
Primary Completion	2030-12-14 (estimated)
Study Completion	2031-12-14 (estimated)
Updated on ClinicalTrials.gov	2025-12-09