A Prospective, Single-center, Phase II Study of Sacituzumab Tirumotecan in Combination With Pembrolizumab for Neoadjuvant Treatment of Triple-Negative Breast Cancer (TNBC)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

October 30, 2026

Study Completion Date

June 30, 2028

Conditions
Neoadjuvant TherapyStage II to III (T1cN1-2 or T2-4N0-2) TNBC Breast Cancer
Interventions
DRUG

Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab

SKB264 will be administered intravenously (IV) at a dose of 4 mg/kg every two weeks (Q2W); Pembrolizumab will be administered intravenously at a dose of 200mg every three weeks (Q3W)

Trial Locations (1)

264000

Department of Breast Surgery, Yantai Yuhuangding Hospital, Yantai

All Listed Sponsors
collaborator

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

lead

Yantai Yuhuangding Hospital

OTHER