Actively Recruiting
Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
Led by QIAO LI · Updated on 2025-08-12
40
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
CONDITIONS
Official Title
Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years with confirmed breast cancer
- ECOG performance status between 0 and 2
- HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) or HER2-low (IHC 2+ without FISH amplification or IHC 1+) invasive breast cancer
- Confirmed brain metastases from breast cancer
- Prior treatments allowed including chemotherapy, HER2-targeted therapy, endocrine therapy, and immunotherapy
- Adequate organ function including neutrophil count ≥1.5 × 10⁹/L, platelet count ≥80 × 10⁹/L, hemoglobin ≥80 g/L, liver enzymes within 1.5 to 2.5 times upper normal limits, normal kidney function, and left ventricular ejection fraction ≥45%
- Voluntary participation with signed informed consent
You will not qualify if you...
- Uncontrolled moderate to large pleural, pericardial effusion, or ascites requiring repeated drainage
- Tumor invading major blood vessels or risk of fatal hemorrhage due to vascular invasion
- Signs of meningeal irritation or confirmed leptomeningeal metastasis
- Uncontrolled or symptomatic hypercalcemia
- Prior cranial radiotherapy
- Prior treatment with trastuzumab deruxtecan (T-DXd)
- History of other malignancies requiring systemic or local treatment except certain skin or cervical cancers
- Major surgery within 4 weeks prior to enrollment or incomplete recovery
- Known or suspected autoimmune diseases except controlled hypothyroidism or stable type I diabetes
- Presence of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases
- HIV/AIDS, active hepatitis B or C, or autoimmune hepatitis
- Severe infections within 4 weeks prior to first dose or active tuberculosis within 1 year
- Previous or planned bone marrow or solid organ transplantation
- Severe or uncontrolled cardiovascular disease including heart failure, arrhythmias, angina, valvular disease, myocardial infarction, or uncontrolled hypertension
- Known hypersensitivity to the investigational drug or monoclonal antibodies
- Pregnant or breastfeeding women or women unwilling to use effective contraception
- History of neurological or psychiatric disorders including epilepsy, dementia, substance abuse
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Q
Qiao Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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