CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 383 enrolled
Drug / intervention
BL-B01D1 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06343948
NCT06343948Phase 3Active

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

Sichuan Baili Pharmaceutical Co., Ltd.·interventional·Posted Apr 3, 2024·Updated Apr 17, 2026

In Brief

A Phase 3 clinical trial evaluating BL-B01D1, Eribulin, and 3 other interventions for HR+HER2- Breast Cancer. Active but no longer recruiting, targeting 383 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 3ActiveOverdue
20252026
First PostedApr 3, 2024
Enrollment StartApr 24, 2024
Primary CompletionMay 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.0 yearsPosted 2.2 years ago

Interventions

BL-B01D1drug

Administration by intravenous infusion for a cycle of 3 weeks.

Eribulindrug

Administration by intravenous bolus for a cycle of 3 weeks.

Vinorelbinedrug

Administration by intravenous infusion for a cycle of 3 weeks.

Gemcitabinedrug

Administration by intravenous infusion for a cycle of 3 weeks.

Capecitabinedrug

Oral administration for a cycle of 3 weeks.