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A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer

Name: A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer — clinical trial record (NCT06957886)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorSichuan Baili Pharmaceutical Co., Ltd.

Started2025-05-15

View on ClinicalTrials.gov ↗

Amendment history

2026-01-19

Study Status, Study Design v2

Enrollment target564→566

2025-05-28

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2025-05→confirmed 2025-05-15

Study sitesdetails revised at 2 of 2 sites

2025-04-27

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 registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.

Trial Details

NCT Number	NCT06957886
Lead Sponsor	Sichuan Baili Pharmaceutical Co., Ltd. Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions	HER2-low Breast Cancer
Enrollment	566 participants
Start Date	2025-05-15
Primary Completion	2027-05 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-01-21