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

StatusActive, Not Recruiting
PhasePhase 3
Started2024-05-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later May 2026 → Oct 2026
See other at-risk trials from Sichuan Baili Pharmaceutical Co., Ltd.

Amendment history

2026-07-22
Study Status v6
Primary completion pushed: 2026-05 → 2026-10
Completion pushed: 2026-05 → 2028-12
2025-08-18
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 268→confirmed 274
Study sitesdetails revised at 1 of 1 site
2025-08-01
2 amendments v3-v4
2 re-verifications since 2024-07-16, no change to tracked fields
2024-05-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04→confirmed 2024-05-08
Study sitesdetails revised at 1 of 1 site
2024-03-17
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2024-03-12
Original filing
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.
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