About this trial
Evaluate the efficacy and safety of Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir in Breast Cancer with Leptomeningeal Metastasis
Eligibility criteria
Qualifiers
Patient is an adult female ≥18 and ≤75 years old at the time of informed consent.
ECGO rating 0-3.
Histologically or cytologically confirmed breast cancer.
A new diagnosis of LM, established either by the presence of malignant cells in the CSF or by the combination of characteristic clinical manifestations and magnetic resonance imaging (MRI) findings
Disqualifiers
Patients with other malignant tumors, excluding basal cell carcinoma and carcinoma in situ
Patients with severe or uncontrolled systemic disease, including uncontrolled hypertension or active bleeding tendency
The investigator considers the patient unsuitable for entry into this study.
Patients with toxicity from prior therapy that has not returned to normal or NCI-CTCAE grade 5.0
Trial design
Treatments tested in this trial
- Intrathecal Administration of Thiotepa in Combination with Methotrexate via the Ommaya Reservoir
Treatment groups
Sponsors and collaborators
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
The Affiliated Brain Hospital of Nanjing Medical University
Collaborator