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

Study acronym: TREND-02
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07271992
Lead Sponsor First Hospital of China Medical University
Collaborators: Liaoning Cancer Hospital & Institute
Conditions
(from sponsor)		 TNBC, Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov