NCT06830889

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,450 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	BL-M07D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	T-DM1	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2025-06-03
• Primary completion: 2031-10-01
• Completion: 2031-12-01
• First posted: 2025-02-17
• Last updated: 2026-01-22

Locations

2 sites across 1 country: China