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A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)

StatusRecruiting
PhasePhase 3
Started2026-09-02
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Recruitment opened
2026-08-25
Study Status, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
2026-07-22
Original filing
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Trial Details
NCT Number NCT07729956
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Triple-Negative Breast Cancer (TNBC)
Enrollment 436 participants
Start Date 2026-09-02
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-30