Actively Recruiting
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-22
1450
Participants Needed
2
Research Sites
338 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, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.
CONDITIONS
Official Title
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years who voluntarily sign informed consent
- Expected survival time of at least 6 months
- Histologically confirmed HER2-positive invasive breast cancer
- Clinical TNM stage T1-4, N0-3, M0 before neoadjuvant therapy (excluding T1N0)
- Residual invasive cancer confirmed by pathology after surgery
- Completed prescribed neoadjuvant therapy
- Underwent radical mastectomy
- Hormone receptor status determined
- Interval between surgery and randomization is between 3 and 12 weeks
- ECOG performance status of 0 or 1
- Previous therapy toxicity recovered to grade 1 or less (NCI-CTCAE v5.0)
- No blood transfusion within 14 days before study drug
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start, not lactating
- Use of effective contraception during treatment and for 7 months after treatment ends
You will not qualify if you...
- Diagnosis of stage IV metastatic breast cancer
- Bilateral breast cancer
- Previous history of breast cancer except lobular carcinoma in situ (LCIS)
- Clinically significant residual, recurrent, or metastatic disease after neoadjuvant therapy and surgery
- Other primary cancers diagnosed within 5 years before study drug
- Prior treatment with HER2-ADC, immunotherapy, or other antitumor biological therapy
- Participation in other clinical trials involving antitumor treatments
- Cumulative anthracycline dose exceeding specified limits
- Severe cardiovascular or cerebrovascular disease within 6 months before screening
- Certain heart conduction problems or uncontrolled arrhythmias
- Poorly controlled high blood pressure
- Severe lung disease or interstitial lung disease requiring steroids
- Positive HIV antibody or active hepatitis B or C infection, or liver cirrhosis
- Serious infection within 4 weeks before study drug
- Recent use of systemic corticosteroids or immunosuppressive therapy
- Severe allergy to study drugs or their components
- History of stem cell or organ transplantation
- Severe neurological or psychiatric illness
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Gastrointestinal diseases like intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Planned or recent live vaccine administration
- Other serious physical or laboratory abnormalities or poor adherence making participation risky or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
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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