Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-02-12; most recent amendment 2026-01-20.
Status change: Not Yet Recruiting → Recruiting 2025-06-23
Trial Details
NCT Number NCT06830889
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions HER2-positive Breast Cancer
Enrollment 1,450 participants
Start Date 2025-06-03
Primary Completion 2031-10 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-22