Actively Recruiting
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-05-02
1600
Participants Needed
2
Research Sites
436 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapy.The primary objective is to compare invasive disease-free survival (IDFS) between SHR-A1811 and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS), overall survival (OS) and distant recurrence-free interval (DRFI).
CONDITIONS
Official Title
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years old
- Pathologically confirmed HER2-positive invasive breast cancer
- Clinical stage before neoadjuvant therapy of T1-4, N0-3, M0 (excluding T1N0)
- Residual invasive cancer confirmed after radical surgery with specific criteria based on clinical stage
- Completed at least 6 cycles of neoadjuvant chemotherapy including taxane-based chemotherapy
- Completed at least 9 weeks of anti-HER2 targeted therapy including trastuzumab
- Received radical surgery for breast cancer
- Interval between surgery and first study medication between 3 and 12 weeks
- Hormone receptor status confirmed postoperatively
- ECOG performance score 0 or 1
- Good heart function
- Agreement to use birth control
You will not qualify if you...
- Stage IV metastatic breast cancer
- Evidence of recurrent breast cancer (local, regional, or distant)
- Other malignant tumors within past 5 years except cured basal cell carcinoma of skin and cervical carcinoma in situ
- Prior systemic anti-HER2-ADC drug therapy including trastuzumab emtansine (T-DM1) or trastuzumab deruxtecan (T-DXd)
- Anthracycline exposure exceeding specified dosage limits
- Significant cardiovascular diseases including severe angina, symptomatic heart failure, serious arrhythmias, or recent myocardial infarction
- Known or suspected interstitial pneumonia
- Known bleeding or clotting disorders
- Active hepatitis B, hepatitis C, or liver cirrhosis
- Serious physical or mental illness or abnormal lab tests increasing study risk
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Z
ZhiYe Chen
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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