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

StatusRecruiting
PhasePhase 3
Started2025-06-03
View on ClinicalTrials.gov ↗

Amendment history

2026-01-20
minor
Study Status v3
Start date2025-06-09→2025-06-03
2025-06-23
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05→confirmed 2025-06-09
Study sitesdetails revised at 2 of 2 sites
2025-02-16
minor
Study Status, Oversight, Conditions v1
Re-verified, no change to tracked fields
2025-02-12
minor
Original filing
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.
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