Clinical Trial

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2026-10 2026-07-24
minor Completion pushed: 2026-05 -> 2028-12 2026-07-24
Trial Details
NCT Number NCT06316531
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions HER2-positive Breast Cancer
Enrollment 274 participants
Start Date 2024-05-08
Primary Completion 2026-10 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-23