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)

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer After Failure of at Least One Prior Line of Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HR+HER2- 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: 2024-04-24
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-04-03
• Last updated: 2026-04-17

Locations

1 site across 1 country: China