NCT07007780

Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

A Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Detailed description

This study is a multicenter, Phase II clinical trial, planning to enroll 35 eligible early-stage TNBC patients who meet the inclusion and exclusion criteria. Patients will receive neoadjuvant treatment with Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks. Imaging assessments will be conducted every 4 weeks during the neoadjuvant treatment phase. After the neoadjuvant treatment is completed, surgery will be performed within 4 weeks of the last study drug administration. Whether to receive adjuvant treatment after surgery will be determined by the investigator. The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety.

Conditions

• Triple -Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Tirumotecan	Sacituzumab Tirumotecan monotherapy before surgery at a dose of 5mg/kg, with a dosing schedule of once every 2 weeks for a total of 12 weeks

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-08-31
• Completion: 2027-08-30
• First posted: 2025-06-06
• Last updated: 2025-07-29