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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)

Name: 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) — clinical trial record (NCT07648914)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2026-07-06

View on ClinicalTrials.gov ↗

Amendment history

2026-07-21

Study Status, Contacts/Locations v2

Recruitment opened

Start dateestimated 2026-06→confirmed 2026-07-06

Study sitesdetails revised at 1 of 1 site

2026-07-08

Study Identification, Study Status v1

Re-verified, no change to tracked fields

2026-06-10

Original filing

Sichuan Baili Pharmaceutical Co., Ltd.

135 trials monitored

See 14 trials at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

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.

Trial Details

NCT Number	NCT07648914
Lead Sponsor	Sichuan Baili Pharmaceutical Co., Ltd. Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions	Breast Cancer
Enrollment	446 participants
Start Date	2026-07-06
Primary Completion	2028-12 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-23