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A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

StatusRecruiting
PhasePhase 3
Started2026-04-21
View on ClinicalTrials.gov ↗

Amendment history

2026-06-03
Study Status, Contacts/Locations v1
Recruitment opened
Start dateestimated 2026-04→confirmed 2026-04-21
Study sitesdetails revised at 2 of 2 sites
2026-04-02
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.
Trial Details
NCT Number NCT07518173
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions HER2-positive Breast Cancer
Enrollment 596 participants
Start Date 2026-04-21
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-04