Clinical Trial

A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

Recruiting Phase 3
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Summary
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-27; most recent amendment 2026-01-19.
Status change: Not Yet Recruiting → Recruiting 2025-05-28
Trial Details
NCT Number NCT06957886
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions HER2-low Breast Cancer
Enrollment 566 participants
Start Date 2025-05-15
Primary Completion 2027-05 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-21