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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)

NCT06343948 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • HR+HER2- Breast Cancer

Interventions

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Eribulin

Administration by intravenous bolus for a cycle of 3 weeks.

DRUG

Vinorelbine

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Gemcitabine

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Capecitabine

Oral administration for a cycle of 3 weeks.

Sponsors & Collaborators

  • Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sichuan Baili Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Binghe Xu · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343948 on ClinicalTrials.gov