Clinical Trial

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)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2026-08 2026-07-24
minor Completion pushed: 2026-05 -> 2027-12 2026-07-24
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