Actively Recruiting
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Led by Fudan University · Updated on 2025-08-21
139
Participants Needed
2
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Preclinical data show no detectable T-DXd/DXd in CSF, though intrathecal trastuzumab demonstrates preliminary safety/efficacy in HER2+ LM. This study evaluates intrathecal/intra-Ommaya T-DXd plus systemic therapy in active HER2+ meningeal/brain metastases, assessing safety, intracranial efficacy, and CSF/peripheral blood T-DXd distribution to clarify BBB penetration potential. Findings may guide novel therapeutic strategies for this high-need population.
CONDITIONS
Official Title
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- HER2-expressing advanced or metastatic breast cancer
- Presence of leptomeningeal metastasis
- For active brain metastases only, at least one measurable lesion in the brain
- Adequate organ and bone marrow function
- No prior radiotherapy, chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or surgery within 2 weeks before enrollment (or within 5 half-lives of prior therapy, whichever is shorter)
- All prior treatment-related toxicities resolved to grade 1 or less
You will not qualify if you...
- Diagnosis of other cancers in the past 5 years except for certain cured or in situ cancers
- Uncontrolled illnesses including active infections, significant heart disease, severe gastrointestinal disorders, or psychiatric/social conditions affecting compliance
- History or current presence of interstitial lung disease or pneumonitis requiring steroids or suspected by imaging
- Significant lung-related health problems
- Use of immunosuppressants or systemic corticosteroids over 10 mg/day within 2 weeks before first dose (excluding nasal/inhaled steroids)
- Active or history of autoimmune diseases with possible recurrence
- Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, HIV, active hepatitis B or C infection (with conditions for HCV antibody positivity)
- Tumor invasion or encasement of major blood vessels or high risk of fatal bleeding during treatment
- Pregnant or breastfeeding women, or those unwilling/unable to use effective contraception
- Any other condition that might affect study participation or outcomes
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, China, 200043
Actively Recruiting
Research Team
J
Jian Zhang, MD, PhD
CONTACT
Y
Yanchun Meng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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