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A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)

StatusActive, Not Recruiting
PhasePhase 3
Started2024-04-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 23, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 2 months later May 2026 → Aug 2026
See other at-risk trials from Sichuan Baili Pharmaceutical Co., Ltd.

Amendment history

2026-07-22
Study Status v6
Primary completion pushed: 2026-05 → 2026-08
Completion pushed: 2026-05 → 2027-12
2026-04-15
Study Identification, Study Status v5
Study title+16 characters
[...] ly Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)
2025-06-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 382→confirmed 383
Study sitesdetails revised at 1 of 1 site
2025-04-30
Study Status, Arms and Interventions v3
Re-verified, no change to tracked fields
2024-05-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04→confirmed 2024-04-24
Study sitesdetails revised at 1 of 1 site
2024-04-03
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2024-03-27
Original filing
This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy.
Trial Details
NCT Number NCT06343948
Lead Sponsor Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions HR+HER2- Breast Cancer
Enrollment 383 participants
Start Date 2024-04-24
Primary Completion 2026-08 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-23