NCT07271992

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• TNBC, Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SG+I	SG 10mg/kg， d1,d8 q3w + I 200mg, d1 q3w 6 cycles （18 weeks）

Timeline

• Start date: 2025-12-15
• Primary completion: 2030-12-14
• Completion: 2031-12-14
• First posted: 2025-12-09
• Last updated: 2025-12-09