Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT06957886

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

Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21

566

Participants Needed

2

Research Sites

132 weeks

Total Duration

On this page

Sponsors

S

Sichuan Baili Pharmaceutical Co., Ltd.

Lead Sponsor

B

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 75 years
  • Willing to sign informed consent and follow study requirements
  • Expected survival time of at least 12 weeks
  • Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer
  • Provide recent tumor tissue samples for HER2 and hormone receptor testing
  • Meet treatment requirements specified in the study plan
  • Have at least one measurable target lesion according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Previous antineoplastic therapy toxicities resolved to grade 1 or less per NCI-CTCAE v5.0
  • Organ function adequate to meet study requirements
  • For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start and not breastfeeding
  • All participants must use effective contraception during treatment and for 7 months after completing treatment
Not Eligible

You will not qualify if you...

  • Received mitomycin C or nitrosourea chemotherapy within 6 weeks before starting study drug
  • Had surgery or radical radiotherapy within 4 weeks before starting study drug
  • Not suitable for control chemotherapy drugs due to intolerance or contraindications
  • Previous treatment with anti-HER2 drugs
  • Prior antibody-drug conjugate therapy with camptothecin derivatives
  • Severe cardiovascular or cerebrovascular disease within the past 6 months
  • Severe lung function impairment from pulmonary diseases
  • History or current interstitial lung disease requiring steroids
  • QT prolongation, complete left bundle branch block, third degree atrioventricular block, or uncontrollable arrhythmias
  • Other primary cancers diagnosed within 5 years before study drug
  • Poorly controlled hypertension
  • Active central nervous system metastases
  • History of severe allergy to study drug components
  • History of stem cell or organ transplantation
  • Anthracycline cumulative dose over 360 mg/m2
  • Positive for HIV, active hepatitis B, hepatitis C, or cirrhosis
  • Serious infection within 4 weeks before starting study drug
  • Large or poorly controlled fluid effusions
  • Carcinomatous lymphangitis
  • Receiving systemic corticosteroids over 10 mg/day or immunosuppressive therapy before randomization
  • Severe neurological or mental illness
  • Significant bleeding or bleeding tendency within 4 weeks before consent
  • Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
  • Planned or recent live vaccine within 28 days before starting study drug
  • Other serious physical or lab abnormalities or poor compliance that increase study risk or interfere with results
  • Investigator judgment deeming patient unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Actively Recruiting

2

Hunan Cancer Hospital

Changsha, Hunan, China

Not Yet Recruiting

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Research Team

S

Sa Xiao, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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