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A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer(PANKU-Breast02)

StatusActive, Not Recruiting
PhasePhase 3
Started2024-06-21
View on ClinicalTrials.gov ↗

Amendment history

2026-07-22
minor
Study Status v7
Primary completion moved earlier: 2026-06 → 2026-01-13
Completion pushed: 2026-06 → 2027-12
2026-04-15
minor
Study Identification, Study Status v6
Study title+16 characters
[...] Locally Advanced or Metastatic Triple-Negative Breast Cancer(PANKU-Breast02)
2025-11-13
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 406→confirmed 418
Study sitesdetails revised at 1 of 1 site
2025-04-30
minor
Study Status, Arms and Interventions v4
Re-verified, no change to tracked fields
2024-09-24
minor
Study Status, Study Design, Outcome Measures v3
Enrollment target436→406
Secondary endpoints6 to 5 entries
Overall survival (OS)
Primary endpoints1 to 2 entries
Overall survival (OS)
Show 2 earlier versions
2024-07-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-05→2026-06
Completion date2026-05→2026-06
Start dateestimated 2024-05→confirmed 2024-06-21
Study sitesdetails revised at 1 of 1 site
2024-05-11
minor
Study Status v1
Re-verified, no change to tracked fields
2024-04-19
minor
Original filing
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure.
Trial Details
NCT Number NCT06382142
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions Triple-Negative Breast Cancer
Enrollment 418 participants
Start Date 2024-06-21
Primary Completion 2026-01-13 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-23