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Eribulin or Vinorelbine or Gemcitabine or Capecitabine for Breast Cancer

Phase 3
Recruiting
Led By Jiong Wu
Research Sponsored by Sichuan Baili Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

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.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Anti-drug antibody (ADA)
Disease Control Rate (DCR)
Duration of Response (DOR)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Eribulin or Vinorelbine or Gemcitabine or CapecitabineExperimental Treatment4 Interventions
Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Group II: BL-B01D1Experimental Treatment1 Intervention
Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinorelbine
2013
Completed Phase 4
~2190
Gemcitabine
2017
Completed Phase 3
~1920
Eribulin
2012
Completed Phase 3
~2740
Capecitabine
2013
Completed Phase 3
~3970

Find a Location

Who is running the clinical trial?

Sichuan Baili Pharmaceutical Co., Ltd.Lead Sponsor
70 Previous Clinical Trials
9,988 Total Patients Enrolled
8 Trials studying Breast Cancer
216 Patients Enrolled for Breast Cancer
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.Industry Sponsor
40 Previous Clinical Trials
4,940 Total Patients Enrolled
6 Trials studying Breast Cancer
158 Patients Enrolled for Breast Cancer
Jiong WuPrincipal InvestigatorFudan University
7 Previous Clinical Trials
785 Total Patients Enrolled
4 Trials studying Breast Cancer
537 Patients Enrolled for Breast Cancer
~291 spots leftby Jun 2026
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