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)
Summary
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.
Timeline
- Start
- 2024-06-21
- Primary completion
- 2026-06
- Completion
- 2026-06
Outcome
Met primary endpoint
release “BL-B01D1-307 is the third Phase III study in which iza-bren has achieved its primary endpoint(s)” systimmune.com ↗
release “met its dual primary endpoints of progression free survival (“PFS”) and overall survival (“OS”) in an interim analysis of a Phase 3 trial (NCT06382142)” bms.com ↗
release “Phase III study in patients with unresectable locally advanced or metastatic triple-negative breast cancer previously treated with taxane therapy met both primary endpoints” sanyoubio.com ↗
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 |