NCT06382142

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

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	BL-B01D1	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Eribulin	Administration by intravenous bolus for a cycle of 3 weeks.
DRUG	Vinorelbine	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Gemcitabine	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Capecitabine	Oral administration for a cycle of 3 weeks.

Timeline

• Start date: 2024-06-21
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-04-24
• Last updated: 2025-11-17

Locations

1 site across 1 country: China