Actively Recruiting
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
Led by Henan Cancer Hospital · Updated on 2026-04-01
150
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.
CONDITIONS
Official Title
Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females and males 18 years or older
- Pathologically confirmed HER2-positive or HER2-low advanced breast cancer
- At least one measurable intracranial lesion according to RANO-BM criteria, untreated locally
- No prior cranial radiation and no need for immediate local treatment or refusal of local treatment
- More than 2 weeks since last systemic treatment; patients with new brain lesions after surgery admitted if no radiotherapy done
- Prior HER2-targeted treatment, endocrine therapy, and chemotherapy allowed
- Life expectancy of at least 6 months
- Adequate function of major organs
You will not qualify if you...
- Leptomeningeal involvement
- CNS complications needing emergency neurosurgery or uncontrolled symptomatic brain metastases
- Previous treatment with trastuzumab deruxtecan or similar antibody drug conjugates containing an exatecan derivative
- Patients who progressed on prior HER2 tyrosine kinase inhibitors excluded from Arm 2
- Patients who progressed on prior bevacizumab therapy excluded from Arms 3 and 5
- Patients who progressed on prior PD-1 or PD-L1 therapy excluded from Arm 6
- No concurrent antitumor therapy for metastatic cancer other than study treatment
- Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week before enrollment
- Participation in other drug trials within 4 weeks before admission
- History of clinically significant lung disease
- Other malignant tumors diagnosed in past 5 years excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma
- Serious concomitant diseases that endanger safety or study completion (e.g., severe hypertension, severe diabetes, active infections)
- Any other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
M
Min Yan, Professor
CONTACT
H
HuiMin Lv
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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