Clinical Trial: NCT06382142
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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief 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.
Official Title
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
Conditions
Triple-Negative Breast Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
Other Study ID Numbers
- BL-B01D1-307
Start Date (Actual)
2024-06-21
Primary Completion Date (Actual)
2026-01-13
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
418
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Information Provided By: | Sichuan Baili Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-07-23 |
Study Overview
Brief 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.
Official Title
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
Conditions
Triple-Negative Breast Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
Other Study ID Numbers
- BL-B01D1-307
Start Date (Actual)
2024-06-21
Primary Completion Date (Actual)
2026-01-13
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
418
Study Type
Interventional
Phase
Phase 3