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)

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT06343948
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • HR+HER2- Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BL-B01D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Eribulin — DRUG
    Administration by intravenous bolus for a cycle of 3 weeks.
  • Vinorelbine — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Gemcitabine — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Capecitabine — DRUG
    Oral administration for a cycle of 3 weeks.

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
383 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-B01D1
    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.
  • Experimental: Eribulin or Vinorelbine or Gemcitabine or Capecitabine
    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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to approximately 24 months ]