At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 58 target
Drug / intervention
BL-B01D1 +1 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.
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating BL-B01D1 and SI-B003 for Breast Cancer. Currently recruiting, targeting 58 participants across 1 site.
Detailed Summary
This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--
Timeline
Phase 2Recruiting
20242025202620272028
First PostedSep 2023
Enrollment StartDec 2023
TodayJul 2026
Primary CompletionDec 2026
Study CompletionDec 2027
First PostedSep 21, 2023
Enrollment StartDec 12, 2023
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 2.8 years agoPrimary completion in 5 months
Interventions
BL-B01D1drug
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
SI-B003drug
SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.