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A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

NCT06316531 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-08-19

No results posted yet for this study

Summary

This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.

Conditions

Interventions

DRUG

BL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

T-DM1

Administration by intravenous infusion 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

  • Erwei Song · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  • Herui Yao · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06316531 on ClinicalTrials.gov