Actively Recruiting
A Randomized Controlled Phase III Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in First-line HER2-positive Recurrent or Metastatic Breast Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-06-04
596
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating the effectiveness and safety of BL-M07D1 combined with Pertuzumab compared to the combination of Docetaxel, Trastuzumab, and Pertuzumab in women with first-line HER2-positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter study aims to provide important data on treatment options for this type of breast cancer. In this trial, participants are randomly assigned to one of two groups. One group receives BL-M07D1 and Pertuzumab administered intravenously every 3 weeks in treatment cycles. The other group receives Docetaxel, Trastuzumab, and Pertuzumab, also given by intravenous infusion every 3 weeks. Participants showing clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons require stopping. Participants will be monitored for up to approximately 24 months to assess progression-free survival as the primary outcome. Researchers will also evaluate overall survival, response rates, duration of response, disease control, clinical benefit, treatment-related adverse events, and development of anti-drug antibodies. Safety assessments and tumor tissue analysis are included. The study involves regular visits for treatment administration, evaluations, and follow-up over the study period.
CONDITIONS
Brief Title
A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years at the time of signing the informed consent
- Histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer
- Clear hormone receptor (HR) status
- At least one measurable target lesion as defined by RECIST v1.1
- ECOG performance status score of 0 or 1
- Toxicity from prior anti-tumor therapy recovered to Grade 1 or less as per NCI-CTCAE v5.0
- Organ function levels meeting study requirements
- Expected survival time of at least 12 weeks
- Agreement to provide eligible tumor tissue specimens
- For premenopausal women with childbearing potential: negative pregnancy test within 7 days before treatment, non-lactating, and agreement to use effective contraception during treatment and for 7 months after completion
- Voluntary signing of informed consent and compliance with protocol requirements
You will not qualify if you...
- Received surgery, radical radiotherapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives before the first dose
- Prior antibody-drug conjugate therapy with camptothecin derivatives as toxins
- History of severe cardiovascular or cerebrovascular disease within 6 months before screening
- Severe lung disease impairing lung function
- History of interstitial lung disease or interstitial pneumonia requiring corticosteroids
- QT interval prolongation, complete left bundle branch block, third-degree AV block, or uncontrolled arrhythmias
- Diagnosis of another primary cancer within 5 years before first dose
- New deep vein thrombosis within 14 days before screening
- Poorly controlled hypertension
- Active central nervous system metastases
- Severe allergic reactions to recombinant humanized antibodies or BL-M07D1 components
- History of stem cell or organ transplantation
- Prior anthracycline therapy exceeding dose limits
- Positive HIV antibody, active hepatitis B or C infection, or cirrhosis
- Severe infection within 4 weeks before first study drug use
- Large or symptomatic serous cavity effusions, poorly controlled
- Systemic corticosteroid therapy over 10 mg/day prednisone equivalent before randomization
- Severe neurological or psychiatric disorders
- Significant bleeding or bleeding tendency within 4 weeks before informed consent
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Planned or recent live vaccines within 28 days before first dose
- Other serious physical conditions, abnormal labs, or poor compliance increasing risk or interfering with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive either BL-M07D1 combined with pertuzumab or docetaxel combined with trastuzumab and pertuzumab. Each treatment cycle lasts 3 weeks, and participants with clinical benefit may continue treatment for additional cycles until disease progression, intolerable toxicity, or other reasons for stopping.
Visits every 3 weeks corresponding to each treatment cycle
Duration - Up to approximately 24 months
Participants are monitored for progression-free survival and overall survival for up to approximately 24 months after treatment.
Periodic visits up to 24 months post-treatment
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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