Status:
RECRUITING
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 therapi...
Detailed Description
Multiple clinical trials have demonstrated the efficacy of systemic T-DXd in advanced HER2-expressing breast cancer with leptomeningeal and/or brain metastases. However, the median survival of leptome...
Eligibility Criteria
Inclusion
- Age ≥18 years, regardless of gender.
- HER2-expressing advanced or metastatic breast cancer
- Leptomeningeal metastasis
- Subjects with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria).
- Adequate organ and bone marrow function
- No radiotherapy, chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or surgery within 2 weeks prior to enrollment (or within 5 half-lives of prior therapy, whichever is shorter).
- All prior treatment-related toxicities must have resolved to ≤Grade 1
Exclusion
- Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, other in situ carcinomas, or papillary thyroid carcinoma.
- Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant cardiovascular diseases, severe chronic gastrointestinal disorders with diarrhea, or psychiatric/social conditions that may compromise compliance with study requirements, significantly increase AE risks, or impair the subject's ability to provide written informed consent.
- History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening.
- Clinically significant pulmonary comorbidities
- Use of immunosuppressants or systemic corticosteroids (\>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose (excluding intranasal/inhaled corticosteroids).
- Any active autoimmune disease or history of autoimmune disease with potential recurrence.
- Uncontrolled infections requiring IV antibiotics, antivirals, or antifungals.
- Active primary immunodeficiency, known HIV infection, active HBV (HBsAg+ with HBV DNA ≥500 IU/mL) or HCV infection. HCV antibody-positive subjects are eligible only if PCR confirms HCV RNA negativity.
- Radiographic evidence of tumor encasement/invasion of major blood vessels, or investigator-determined high risk of fatal hemorrhage due to probable vascular invasion during treatment.
- Pregnant/lactating women, or subjects of reproductive potential unwilling/unable to use effective contraception.
- Any other condition deemed by investigators to potentially affect trial conduct or outcome interpretation.
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT07134153
Start Date
April 18 2025
End Date
February 28 2027
Last Update
August 21 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
2
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, China, 200043