Actively Recruiting
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Led by Fudan University · Updated on 2025-11-25
37
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
CONDITIONS
Official Title
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or above
- Able to understand the purpose, benefits, and risks of the trial and willing to sign informed consent
- Eastern Oncology Consortium (ECOG) physical status score of 3 or less
- Histologically or cytologically confirmed HER2-negative metastatic breast cancer
- Failure or intolerance of standard treatment
- Presence of leptomeningeal metastasis confirmed by malignant tumor cells in cerebrospinal fluid or clinical symptoms with brain MRI indicating pia enhancement
- Good major organ function confirmed by laboratory tests including platelet count ≥80×10^9/L, hemoglobin ≥8g/L, neutrophil count ≥1.5×10^9/L, serum creatinine ≤1.5×ULN, ALT and AST ≤3×ULN (or ≤5×ULN if liver metastases), serum total bilirubin ≤1.5×ULN, INR and APTT ≤1.5×ULN
- NYHA cardiac function grade II or less, with no significant ECG abnormalities
- Willing to comply with trial protocol and regular follow-up
- For women of childbearing age and fertile men or their partners, negative pregnancy test within 7 days before enrollment and use of effective contraception during the study period until 6 months after last dose
- Recovery from non-hematological toxicity (CTCAE ≤ class 1) from last treatment except alopecia, with no safety risk as assessed by investigator
You will not qualify if you...
- Pregnant or lactating women
- Acute or chronic infections or other serious diseases that make participation unsuitable
- Other malignant tumors within 5 years except certain cured or non-recurring cancers
- Mental illness or disorders causing poor compliance
- Serious organic diseases or major organ failure such as decompensated heart and lung failure
- Bleeding tendency
- History of organ transplants
- Long-term use of adrenal corticosteroids or immunosuppressants
- Intracranial hemorrhage unrelated to tumor disease
- Central nervous system complications requiring urgent treatment
- Inability to collect cerebrospinal fluid (for test group)
- History of immunodeficiency including HIV positive or other immunodeficiency diseases
- Active viral hepatitis B or hepatitis C unless stable on antiviral therapy
- Serious cardiovascular conditions including congestive heart failure, recent myocardial infarction, unstable angina, malignant arrhythmias, prolonged QTcF, or uncontrolled high blood pressure
- Other conditions deemed 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
Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jian Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here