Actively Recruiting
A Randomized Controlled Phase III Study of BL-M07D1 Versus Trastuzumab Emtansine (T-DM1) for 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
8 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
Researchers are evaluating BL-M07D1 compared to T-DM1 for the adjuvant treatment of HER2-positive breast cancer in women who have residual invasive cancer after neoadjuvant therapy. This phase III, randomized, open-label, multicenter study aims to assess the effectiveness and safety of BL-M07D1 in this specific breast cancer population. Participants receive either BL-M07D1 or T-DM1 through intravenous infusion every three weeks for each treatment cycle. Those who benefit clinically may continue receiving additional cycles. Treatment may stop if the disease progresses, intolerable side effects occur, or for other reasons. This study follows participants for up to approximately 77 months to monitor outcomes. During the trial, participants will undergo regular assessments to measure invasive disease-free survival, disease-free survival, distant recurrence-free interval, overall survival, and treatment-related adverse events. The study includes scheduled visits for treatment administration and safety monitoring. Participants are involved for the duration of treatment and follow-up, which may last up to about 6.5 years.
CONDITIONS
Brief 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 at the time of consent
- Signed informed consent and willing to follow protocol requirements
- 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 meeting protocol conditions
- Completed prescribed neoadjuvant therapy
- Had radical mastectomy
- Hormone receptor status determined
- Interval between surgery and randomization between 3 and 12 weeks
- ECOG performance status 0 or 1
- Toxicity from previous anti-cancer therapy returned to grade 1 or less
- No blood transfusion within 14 days before first study drug use
- Premenopausal women with childbearing potential must have negative pregnancy test and use effective contraception during treatment and for 7 months after
You will not qualify if you...
- Diagnosis of stage IV metastatic breast cancer
- Bilateral breast cancer
- Previous breast cancer history except lobular carcinoma in situ
- Clinically significant residual, recurrent, or metastatic disease after therapy and surgery
- Other primary cancers diagnosed within 5 years before first dose
- Previous HER2-ADC, immunotherapy, or other antitumor biological treatments
- Participation in other cancer clinical studies with anti-tumor treatment
- Prior anthracycline treatment exceeding specified cumulative doses
- Severe cardiovascular or cerebrovascular disease within 6 months before screening
- Heart conduction abnormalities or uncontrollable arrhythmias
- Poorly controlled hypertension
- Severe lung diseases impairing function
- History or current interstitial lung disease or pneumonia requiring steroids
- HIV positive or active hepatitis B/C or liver cirrhosis
- Serious infection within 4 weeks before first dose
- Use of systemic corticosteroids or immunosuppressive therapy within 2 weeks before first dose
- History of severe allergy to study drug components
- Known hypersensitivity or contraindications to T-DM1
- History of stem cell or organ transplantation
- Severe neurological or psychiatric illness
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Intestinal obstruction or severe bowel diseases
- Planned live vaccination or live vaccine within 28 days before first dose
- Other serious health or laboratory abnormalities or poor adherence increasing study risk or affecting results
- Investigator judgment deeming participant unsuitable for study participation
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 intravenous infusion of either BL-M07D1 or T-DM1 in 3-week cycles. Treatment continues with additional cycles if clinical benefit is observed, and may end due to disease progression, intolerable toxicity, or other reasons.
Infusion visits every 3 weeks
Duration - Up to approximately 77 months
Participants are monitored for invasive disease-free survival, overall survival, and treatment-emergent adverse events after treatment completion.
Regular follow-up visits over the monitoring period
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
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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