drugset / Trial / NCT06343948
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)
Phase 3
Active not recruiting
383 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-04-24
- Primary completion
- 2026-05
- Completion
- 2026-05
Outcome
Met primary endpoint
release “BL-B01D1-306）中，经独立数据监查委 员会（iDMC）判断，在预设的期中分析中达到无进展生存期（PFS）主要终点” cninfo.com.cn ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BL-B01D1 | Unknown | — | Intravenous |
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | Eribulin | Small molecule | — | Intravenous |
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Vinorelbine | Small molecule | — | Intravenous |