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

NCT06957886 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

  • HER2-low Breast Cancer

Interventions

DRUG

BL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel

Oral administration of Capecitabine. Administration by intravenous infusion of Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel.

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
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2027-05-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06957886 on ClinicalTrials.gov