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)

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.

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	2026-08
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-28