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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 After Failure of Prior Endocrine Therapy(PANKU-Breast03)

NCT07648914 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2026-07-23

No results posted yet for this study

Summary

This trial is a registrational 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 prior endocrine therapy.

Conditions

Interventions

DRUG

BL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Albumin-Bound Paclitaxel

Administration by intravenous infusion for a cycle of 4 weeks.

DRUG

Paclitaxel

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT07648914 on ClinicalTrials.gov