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Study identifier: NCT07729956 Synced from ClinicalTrials.gov · July 28, 2026
● Not Yet Recruiting

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)

Condition: Triple-Negative Breast Cancer (TNBC)  ·  Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

PhasePhase 3
Planned participants436
Who can joinFemale, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sa Xiao, PHD  ·  +8615013238943  ·  xiaosa@baili-pharm.com

Always discuss trial participation with your own doctor first.

Locations (1)

Fudan University Shanghai Cancer CenterShanghai, Shanghai Municipality, China

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Source record: clinicaltrials.gov/study/NCT07729956