Clinical 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)
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 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.
Official Title
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
Conditions
HR+HER2- Breast Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
Other Study ID Numbers
- BL-B01D1-306
Start Date (Actual)
2024-04-24
Primary Completion Date (Estimated)
2026-08
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
383
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 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.
Official Title
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
Conditions
HR+HER2- Breast Cancer
Intervention / Treatment
- Drug: BL-B01D1
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
Other Study ID Numbers
- BL-B01D1-306
Start Date (Actual)
2024-04-24
Primary Completion Date (Estimated)
2026-08
Study Completion Date (Estimated)
2027-12
Enrollment (Actual)
383
Study Type
Interventional
Phase
Phase 3